Good morning. My name is Victor, and I'll be your conference operator for today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics Conference Call to announce the FDA's accelerated approval of Xplovio. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request.
I would now like to turn the call over to Mr. Chris Primiano, Cary Farms, Chief Business Officer And General Counsel. You may begin.
Thank you, Victor, and thank you all for joining us on this very exciting occasion to discuss the FDA's accelerated approval of Spovio, also known as selinexor, for the treatment of adult patients with highly refractory multiple myeloma. This is Chris Permiano, and I'm joined today by Doctor. Sharon Shackam, Founder, President, Chief Scientific Officer and inventor of Xpobio, Doctor. Michael Kaufman, Chief Executive Officer Mr. Perry Monaco, Senior Vice President of Sales, and additional members of our executive team will be will be available to answer questions in the Q And A portion of today's call.
On the call today, Doctor. Kaufman will provide an overview of approved indication by the FDA for Xpovio, and we'll review some of the key clinical data that is served as the basis for this approval. He will also highlight the important actions we are undertaking so that patients and their caregivers are effectively supported throughout the treatment experience with Expovio. Following Doctor. Kaufman's remarks, Perry Monica will discuss the multiple myeloma market and will describe our commercial preparations and strategic plans support a successful commercial launch in the United States.
Harry joined Karyopharm in early 2018 to lead the development of our sales strategy and to build out our field based sales organization. He has spent over 20 years in the commercial oncology hematology space, including more than 7 years myeloma. Following Perry's remarks and some concluding remarks for Michael, we will open the call to answer your questions. Earlier today, we issued a press release detailing the accelerated approval of Xpobio by the FDA. This release as well as this webcast presentation is available in the Investors section on our website at karyopharm.com.
Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and timelines to potential success of our product candidates financial projections and our plans and prospects. Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent quarterly report on Form 10 Q, which is on file with the SEC and other filings that we may make with the SEC in the future. Any forward looking statements represent our views as of today only. While we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change.
Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Doctor. Michael Kaufman, Chief Executive Officer of Keriopharm.
Thank you, everyone. Thank you, Chris, and good morning. Good afternoon. Want to thank everybody for joining us here. My voice is a little off today.
As you can imagine, there's been a little bit of excitement around the company. I'm thrilled to be with you today. Formally announce the accelerated approval by the FDA of Xpovio indicated in combination with dexamethasone for the treatment of adult patients with relapsed for refractory multiple myeloma, so called RMM, who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors least 2 immunomodulatory agents and an anti CD38 monoclonal antibody. This indication is approved under the FDA's accelerated approval program, developed to allow for expedited approval of drugs to treat serious conditions and then fill an unmet medical need. The approval of exposure was based upon the efficacy and safety observed in prespecified subgroup analysis of part 2 of the STORM study comprised of 83 patients whose disease was confirmed to be refractory to bortezomib carfilzomib lenalidomide, and daratumumab.
Continued approval for this indication may be continued upon patient and description of clinical benefit in a confirmatory trial. The ongoing Phase III BOSTON study will serve as that confirmatory trial, and we expect to have top line results from the BOSTON study by the end of this year or early next year, depending on the occurrence of progression free survival events in the trial. As many of you know, Karyopharm was founded about 10 years ago by Doctor. Sharon Shackham to focus on the discovery and development of nuclear transport modulators. Over expression of the nuclear export protein, exports in 1 or Xp01, is observed across numerous tumor types, and nuclear export dysregulation is increasingly recognized as a fundamental mechanism of oncogenesis by inactivating tumor suppressor and other growth regulatory proteins.
Doctor. Shaffnam set out to find compounds that could attenuate the abnormally high levels of nuclear export across observed in cancer cells. In 2010, she discovered novel small molecule inhibitors of XB-one and this new class of agents was called selective inhibitors of nuclear export or sign compounds. Now branded Xpobio, selinexor is the first sign compound to enter clinical development in 2012. A broad Phase I program with oral agent was undertaken in both hematologic and solid tumor malignancies with evidence of anti cancer activity, reported in several areas.
Based on the high unmet medical need and the initial phase 1 results, we decided to focus our clinical efforts on a population of patients. With multiple myeloma. This disease was refractory to available agents and therefore whose prognosis was particularly poor And the STORM study for selinexor treatment of refractory myeloma was opened to Xpovio in combination with low dose dexamethasone in patients the Kiley refractory myeloma. Fast forwarding today, I am thrilled to announce today that Xpovio is now the 1st and only nuclear inhibitor approved by the FDA. And additionally, Xpobio is now the 1st and only prescription medicine approved for adult patients whose myeloma is refractory to proteasome inhibitors, immunomodulatory agents, and an anti CD38 monoclonal antibody.
As to be expected, there is also important safety information included in the Expobio product label. Notably, there are no black box warnings or contraindications in the label. A patient medication guide will be available to educate on the expected adverse reaction profile for EXFOIA. Additionally, there are some important details regarding patient monitoring instructions and warnings and precautions included in the label. We expect these instructions, including the recommended supportive care guidelines and dosage modification criteria to be straightforward and easy for healthcare provider providers and patients to follow.
Specifically, physicians are recommended to administer concomitant serotonin antagonist and or other anti nausea agents when describing EXBOVIO and to monitor body weight during the treatment. Standard lab tests, including the bleed blood counts and serum chemistry are also recommended during treatment. Finally, adverse reactions are recommended to be addressed by using dosage modifications in supportive care with specific recommendations for both included in the prescribing information for the common adverse reactions associated with Xpobia. Complete details of these guidelines along with the complete prescribing information can be found at www.expobio.com. Before I describe the efficacy and safety data that serves as the basis for Expovyo's accelerated approval, it's important to understand just how heavily pretreated and vulnerable the patients were in a pivotal storm study.
This provides important context in reviewing the efficacy of safety data. In fact, currently available real world data suggests that patients with this level of advanced refractory myeloma have a median life expectancy of between 3 and 5 months. 202 total patients were enrolled in Storm with 122 patients enrolled in Part 2 of the study. All patients in part 2 of the study have been previously treated with the 5 standard of care myeloma drugs available. Additionally, there were specifically 83 patients confirmed to have disease refractory to the 5 drugs, which include bortezomib, parfelzumab lenalidomide phenylinamide and Daratumumab.
The major efficacy outcome measure for Xpobia was established based upon the overall response rate in these 83 patients who, in addition to having highly refractory disease, had been treated with a median of 8 prior drug regimens, over the last 7 years and at 57% in high risk cytogen egg markers, which further predict a core prognosis. Additionally, the patients in part to a storm had rapidly progressive myeloma with a median increase in disease burden 22% in just the 12 days from screening to the patient's first dose of Xplovia. Finally, not only did patients have heavily pretreated and progressive disease, but they also had a median of 10 comorbidities, which included moderate to severe renal dysfunction, and various cytopenias, including thrombocytopenia. Patients were allowed to be receiving any concomitant medications when they entered the study. Therefore, we believe the patients enrolled in Storm Part II represent the kind of real world patients with highly refractory myeloma.
That many treating physicians in the U. S. Would expect to see in their clinics. Additionally, these patients had the most refractory disease included in any sizable myeloma clinical trial to date. I will now highlight some of the key efficacy data from the 83 patients in this study who served as the basis for Xpovio's accelerated approval.
25.3 percent of these patients achieved a partial response or better as defined by the International Myeloma Working Group, and is assessed by an independent review committee, and therefore, the study met its primary endpoint. Importantly, Expall Bio was able to achieve significant depth of response with one patient out of 83, achieving a stringent complete response, and another 4 patients achieving a very good partial response, which means a 90% reduction in their disease burden. Additionally, most patients who responded to Xpovio achieved a response within the 1st 4 weeks of treatment and the median duration of response was 3.8 months. While it's important to highlight the overall response rate in the 83 patients who served as the basis for accelerating Xpovia's accelerated approval, We believe that it's also important to have a broader perspective on the responses and overall survival data from the entire patient population in part 2 of the storm study. These data were presented at ASH 2018, and we have previously highlighted them in earlier investor presentations.
Specifically, What you'll see on the left side of this slide is a waterfall plot of the responses of 100 and 22 patients in STORM part 2. First, Remember, the patients entering part 2 of the study had rapidly progressing disease of the median 22% increase in disease burden in just 12 days between screening of the study and therapy initiation. The waterfall plot shows despite the rapid progression on study entry. 71% of the patients had a reduction in their disease burden. Each of these bars represents the maximal tumor load reduction for each individual patient These results show that most of the patients on Part 2 of STORM experienced a halt of disease progression and a reduction in their disease burden.
These results further support our rationale and enthusiasm for the ongoing randomized BOSTON study being conducted in patients with relapsed multiple myeloma at or 1 to 3 prior therapies. Now turning to overall survival. As I mentioned previously, patients who entered Storm Part II with heavily pretreated and refractory myeloma have an expected median survival of only 3 to 5 months based on recent published literature. On the right side of this slide, you will see the overall survival data from the 122 patients in part to a storm with a median of 8.6 months. Of overall survival across the whole patient population.
Also notable was the median survival seen in the nearly 40% of patients who had at least minimal responses to Xphobia. These patients had a median overall survival of 15.6 months This compares to a median survival of only 1.7 months in the patients whose disease progressed or was not evaluable in the study. As a reminder, these data come from all of the 122 patients in part to a store. We note again that the approved label indication for Xplovio was based on the subset of 83 patients whose disease was confirmed to be refractory to all 5 of the standard of care myeloma drugs available today. Exposvio has a well characterized safety profile with more than 1000 patients with hematologic malignancies treated in clinical trials to date, including 202 patients with myeloma, who received oral Xpovio 80 makes in combination with dexamethasone 20 makes on days 1 3 weekly, parts 1 and 2 of storm.
In the storm study, the most common adverse event reactions with an incidence of over 20% were from cytopenia, fatigue nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponastremia, neutropenia, lupopenia, Constipation dyspnea and upper respiratory tract infection. The rate of fatal adverse reactions was 8.9%, and the treatment discontinuation rate in the study was 27%. The types of adverse reactions were consistent with what would be expected in older patients highly refractory myeloma, who've been heavily pretreated in many tests underlying comorbidities. Along these lines, 53% of the patients had a reduction in their Xplovio dosage and 65% of patients had the doses of Xplovio interrupt. These dose modifications to address adverse reactions were often effective for improving symptoms and reducing discontinuations.
For example, 44% of patients had a dose modification to address an adverse reaction of thrombocytopenia, while only 3% discontinued treatment due to this adverse reaction. Based on the results from the STORM study, we believe that physicians will be able to detect, monitor and manage their adverse reactions through dose modifications standard supportive care. Importantly, we are committed to educating and supporting patients and their caregivers and have developed 5 key initiatives to support Xpovio use. 1st, we intend to educate prescribers and their staff about what to expect while on treatment with Xpovio. We are planning for a team to train nurse liaisons to provide guidelines around the management of Expelvio adverse reactions.
2nd, We have a dedicated network of specialty pharmacy staff and oncology trained nurses available 20 fourseven and anticipated myeloma advocacy group will also support patients to help optimize their treatment. Next, as per the label, we intend to recommend regular monitoring of complete blood count basic certain chemistry and body weight. 4th, we plan to communicate the management of common adverse reactions with clear guidance on dosage modifications and supportive care. That should be delivered prophylactically or as needed. And finally, we expect to communicate clear stopping criteria for disease progression in 1 to 2 months or for significant adverse reactions despite those modifications and supportive care.
With the review of the efficacy and safety data now complete, like to turn the presentation over to our Senior Vice President of Sales, Perry Monica, who will review our commercial launch plans, and then I'll make some final remarks before we head into the Q And A portion call. Harry?
Thank you, Michael. It's great to join you on this call to highlight the preparations we have made to support a successful commercial launch of Xpovio. Before I describe our specific commercial plans, I want to provide a brief description of the multiple myeloma landscape where there remains a significant need for additional novel treatment options. Multiple myeloma is the 2nd most common blood cancer in the U. S.
With roughly 32,000 new cases each year, and 130,000 patients living with the disease. It's a disease that disproportionately affects our aging population with a median age at diagnosis of sixty nine years old. And while there have been a number of new treatments approved in recent years, regrettably, the disease remains incurable and the vast majority of patients will develop refractory will develop disease refractory to the currently available treatment options. And unfortunately, there are expected to be nearly 13,000 deaths due to multiple myeloma this year in the U. S.
Of the patients living in the of the patients in the U. S. Living with multiple myeloma, it is estimated that roughly 69,000 patients will be treated with drug therapy annually. While we cannot predict with certainty, how many of the relapsed refractory patients will be appropriate candidates for Xpovio We estimate that there are approximately 6000 patients being treated with their 4th or later line of therapy, and we know that patients typically receive between 2 to 4 different drugs in combination in each line of therapy. With the approval of Xpovio, our commercial team will now be focusing on 4 core launch imperatives.
First, our goal will be to establish nuclear export inhibition as a novel fundamental approach in the treatment of multiple myeloma. With a clinically meaningful side or efficacy profile in disease in patients with disease refractory to at least 2 proteasome inhibitors. At least 2 immunomodulatory agents and an anti CD38 monoclonal antibody. Next, we will seek to minimize potential access barriers to support appropriate patients and patients on the adverse reaction profile of Xpobio and the related management strategies, which you heard Michael outline earlier on the call. A successful commercial launch in 2019 will also help set the stage for potential future launches and additional indications in both myeloma and across tumor types currently in clinical development, pending future regulatory approvals, of course.
While the recommended starting dose for EXPARELTO is 80 milligrams taken twice per week, we do expect physicians to tailor the dose to best meet the needs of each individual patient. A practice that is common for many cancer medications. In order to support dosing flexibility, we intend to launch Expobio in 4 different 4 week dosing package sizes of Xpovio 20 milligram tablets. As we believe, the value of Xpovio to the patient is independent of what dosing regimen is most appropriate, we have decided to price all 4 available dosing packages at the same wholesale acquisition costs of $22,000 per month. We do not believe pricing considerations should influence what dose of Xpovio a patient is prescribed and therefore, we have decided to take this flat pricing approach.
Finally, as we've been preparing diligently for FDA approval, I am happy to announce that we have an ample supply of Expovio already manufactured and we will expect Expovio to be commercially available to patients on or before July 10, 2019. As we now prepare to launch Expobia to health care providers, I'd like to share some First, nearly 80% of these physicians are already aware of Xpovio. Next, nearly 50% field they do not currently have effective treatment options for 4th line plus patients and they believe the kinds of patients studied in the STORM trial represent a patient population
with
is its novel mechanism of action and resulting efficacy, but they also believe its oral administration is a meaningful benefit. And finally, they share our view that the adverse reaction profile is likely manageable, but will require proactive communication to ultimately support both physicians and patients. I am pleased that our sales, marketing and account management teams are already fully hired trained and ready to launch X Covio immediately. We have hired and trained more than 70 sales representatives in nurse liaisons, They will focus on the 1300 accounts who treat roughly 80% of all multiple myeloma patients with an emphasis on the 400 accounts caring for one half of all patients. Based on the clinical profile of Xpovio and its oral administration of delivery, We expect that Expobia will be prescribed by both myeloma treaters at large academic institutions, as well as at community based oncology practices.
We are fortunate to have a deeply experienced commercial organization in particular, our field force members have an average of 20 years of pharmaceutical experience including an average of 12 years in the hematology oncology space and 5 years specifically selling other multiple myeloma drugs. Additionally, we have a highly experienced account management And we have implemented an extensive patient and physician support program that I will highlight on the next slide. We have implemented a comprehensive program to support patients, their caregivers and healthcare providers, and we have named it carry forward. The carry forward program services will include the following: patient and caregiver focused content and support benefits investigation, reimbursement support, side effect management tools and access to nurses at the patient support center on the phone who will be available to answer questions regarding expectations with Expovio Treatment. Additionally, we have decided to establish a focused distribution network of 3 highly experienced oncology specialty pharmacy providers to exclusively support patients who are prescribed Xpovio.
These 3 providers have extensive experience with specialized oncology medicines and will provide additional support to patients who are prescribed Xpovia. In summary, we are confident that we have put all the right people, strategies and initiatives in place to effectively support the commercial launch of Expevia. I'd now like to hand the call back over to Michael who will provide some final thoughts. Michael?
Thank you, Perry. Let me also acknowledge what a terrific job that you and the commercial team have done in helping carry a farm prepare for its first product launch in the United States I look forward to watching you and your team implement the critical strategic imperative I just outlined. I'd also like to acknowledge anon Veriden, our Chief Commercial Officer, who has played an integral role in our commercial preparedness. Anon will be leading Karyopharm and we wish him well in his future endeavors and are appreciative of his contributions over the last year. While today's approval announcement, of course, a landmark moment for myeloma.
I would like to briefly highlight some additional upcoming milestones for exposure. Later this year and into the first half of next year, We expect some additional important events, including a regulatory decision in Europe for the potential EXPOVIO conditional approval in heavily pretreated myeloma patients by year's end. The top line data from the BOSTON study, which if positive, would lead to an additional regulatory filing next year and earlier in line multiple myeloma. The timing of the Boston data depends on progression events that could come by year's end or early next year. And the planned submissions in the United States and Europe requesting accelerated and conditional approval in diffuse large B cell lymphoma based on the data generated from the Phase 2b SADAL study.
And then as we look out into the second half of twenty twenty and beyond, we expect Phase III data from Xpovio in liposarcoma and endometrial cancer as well as additional geographic regulatory filings and commercial launches in multiple myeloma and DLBCL following these potential regulatory approvals. Let me provide cover and develop novel nuclear transport modulators at Karyopharmatexico. Our team has taken a highly innovative idea through development and an additional regulatory approval of courage, urgency, resilience and energy, exemplifying some of the best scientific and medical leadership in the biopharmaceutical Blinds. The FDA's accelerated approval exposure marks the 1st nuclear export inhibitor and the only medicine approved for patients whose disease is refractory to all 5 of the most commonly used anti myeloma drugs. We expect commercial product to be available on or before July 10, 2019.
Our field force and patient physician support initiatives are already in place. To immediately support the commercial launch. Key product features of Xpovio include a novel mechanism of action, signal agent activity in combination with low dose dexamethasone, predictable and manageable tolerability profile without significant major organ toxicities and no black box warning. And oral administration with convenient dosing. And finally, I'd like to close my formal remarks by offering my very sincere appreciation to all of the patients, their families, physicians, caregivers, advocacy organizations, carry off farm employees, the FDA, and investors in our company who have helped to get us to this monumental day.
There is no way we could have gotten here without all of your dedication and persistence. And your support. And for that, we are immensely thankful. With that, I'd like to turn the call back over to the operator so he can answer some of your questions.
You. And our first question comes from the line of Brian Abrahams from RBC Capital Markets. You may begin.
Hi there. Thanks very much for taking my questions and congratulations on the approval. First question for me, I was wondering if you had any clarity from the agency as to what's going to be required from the BOSTON study in order to maintain Xprobeo in the market? And then I had a couple of follow ups.
Yes, this is the same situation as the other, the many other accelerated approvals in myeloma that we they expect to see the data. As mentioned at ODAC, they expect to, we hopefully will have a positive effect on the primary endpoint, which is the progression free survival endpoint. And assuming that all works out, then that'll maintain, exposure and also allow it to be moved up into second line or later therapy. Got it.
And we know that the PDUFA was obviously pushed out a bit to for the agency in order for the agency to consider new data. Can you talk a little bit about what was shared with respect to some of the ongoing and previous studies with the FDA on safety and efficacy that swayed them make the approval decision despite the mixed adcom?
Yes. First of all, it's important to remember that they not only look at the total vote on the ad but also the quantitative and content of each of the voters and the they consider the backgrounds of the different depositions involved. On ODAC and the other representatives on ODAC. So that's one point. 2 is, I'd be referring to the FDA press release describing the approval of Xpovio.
They did provide a bit more insight into that, than we than they've asked us to provide. And if I can, briefly, if you give me one second, I will quote, from the FDA that, as they mentioned, the efficacy evaluation was supported by additional information from an ongoing randomized trial in patients with multiple myeloma. Without being cute, the only ongoing randomized trial in myeloma that we have now is Boston. So they did, as we mentioned publicly, they did look at some of the DSMB results and that helped with their thinking.
Very helpful. Last one for me. What are the what impact does this have on your plans to file now in DLBCL for accelerated approval, the strategy and timing there? I'm curious, was there any reference to that indication during your discussions that might give you confidence in pursuing a path there as well? And I'll hop back in the queue.
Yes. So, on the DLBCL, as we mentioned, obviously, any approval gives us, gives FDA certainly more insight into the drug. We'll be, we'll be, looking to file that end of year or the beginning of next year pending further discussions with the agency.
Thanks, Michael, and congratulations to you and the team.
And our next question comes from the line of Maury Raycroft from Jefferies. You may begin.
I'd like to add my congrats as well. And thanks for taking my questions. So I was just wondering based on the market research that you did and based on your understanding of how selinexor works from the SOMP study and the other ongoing studies, give a sense of whether doctors will add cell plastex on top of that 4th line of treatment or will the patient have to completely wash out before cell index are added?
We can only comment on the act labeled indication for selinexor dexamethasone in the lines, how doctors choose to treat patients is between them and the patients.
Very good. And just to clarify on the data from Boston that was submitted to the FDA, for review. So you mentioned that they looked at information from the DSMB review Was it, can you comment at all on the level of efficacy data that was included in that?
We cannot, we're not privy to those data. That was a third party discussion.
Okay. Okay. Very good. Congrats again and I'll hop back in the queue. Thanks.
And our next question comes from the line of Jonathan Chang from SVP Leerink. You may begin.
Hi, congrats on the approval. And thanks for taking my questions. First question, And just to follow-up on the previous question, can you clarify how the Boston readout could impact today's approval, I guess, as it pertains to both efficacy and safety data?
The guidance around accelerated approval, which is also listed in the package insert, and it's true for all accelerated approvals is that this indication that was granted on accelerated approval may be contingent upon further verification in confirmatory trials, and that's basically what we can say.
Okay, got it. And second question, in the past, you've spoken about the potential advantages of selinexor being an oral drug and how this could have an advantage in the community setting. What are your latest thoughts on this? I guess especially with the additional detail you provided today on physician education and monitoring of adverse events?
I'll start and I'll turn it over to Perry. The team has come up with a comprehensive set of supportive care, which will be to be used extensively and offered to any patient who's receiving selinexor and any doctor that's considering treatment with it. And we feel very comfortable that we are able to provide the most up to date and optimal care that we have found is available, based on existing clinical trials. Harry, can you comment additionally on the oral and the support of care?
Sure. So we do have a full team of nurse liaisons who will be working very closely with accounts, whether it's a large academic institution or a smaller community based practice on the proper ways to help manage patients through any side effects that they may see. The general nature of the patient being later stage a lot of those patients choose to take therapy at home and even some of your rural community places, that's a distinct advantage for an oral medication but there's definitely flexibility for both large academic institutions and the community based practices.
Got it. Thank you and congrats again.
Thank you. And our next question the line of Arlinda Lee from Canaccord.
First, could you clarify, Michael, on the additional information that FDA considered from Boston? Did that include both Safe and efficacy? And then maybe, Perry, on dose interruptions, you've provided a lot of information on dose interruptions, instead of, to help prevent discontinuation, how long were these patients interrupted for And then lastly, on the A. E. Monitoring in the label, how different is that from what you did in clinical trials and community practice and what you think might be standard and community practice?
Thanks.
Okay. A lot of stuff. I'll start with the first one. Very simply on, on we as we discussed, at the time, we had a DSMB evaluation and it included safety and efficacy. And this was done to a third party as is typical in these kinds of randomized studies, and we're not privy to that information.
It was shared with the agency. So we assume it included both safety and efficacy. On the second issue, we can say that the majority of the interruptions would be for less than 2 weeks, and many of them would be, in 1, sometimes only 1 week. Of interruption. And this was all learning that was done and included all that learning we've included now on our materials going forward.
I'll switch it over now to Perry and talk a little bit about the education.
Yes. So if you think about the patients that were included in the STORM trial, these are heavily pretreated patients and there's a lot of comorbid conditions that they come on with. And it does require a certain level of oversight. And I think that that's where, again, our team of nurse liaising liaisons is going to be very helpful. To towards educating the accounts on the right ways to manage these patients, the right supportive care and also through dose modifications.
We believe that it's extremely important this latent therapy to try and keep patients on, but it does require some navigation.
Okay.
Thanks.
Our next question comes from the line of Ted White from H. C. Wainwright. You may begin.
Congratulations guys. It's actually Ed White. And, just I think all my questions on the launch were answered. Maybe you can just give us an update on Europe. We know that the regulatory decision in Europe is expected late this year.
Maybe you can tell us a bit about the strategy there and potential partnering? Thanks.
Certainly. Simply put, as mentioned, the decision should be on regulatory in Europe for conditional approval towards the end of the year. We are exploring 2 separate options there. 1 is a partnership with a focus in Europe and the other one is for us to go it alone And that go it alone strategy would be more of a focused strategy on a country by country basis focused on those countries where, discussions with regulators and reimbursement can be maintained more rapidly, and then delaying depending on which the country is based on their timing for approvals and reimbursement. So those are the simple forks in the road, if you will.
And do you know when you're going to make that decision whether to partner or go it alone, would that be at the time of approval or would you be able to give us some guidance on that before approval?
We'll make that decision when it's appropriate pending discussions and, explorations of both of those avenues in more detail. We have a lot of ongoing discussions now. That's all I'm prepared to say.
Okay, great. Thanks, Mike, and congratulations again.
Thank you very much.
And our next question comes from the line of Michael from Baird. You may begin.
Taking the question and congratulations on the approval as well. Just had a question on diffuse large B cell lymphoma. I think you mentioned potential filing sort of year end or early next year. I'm just curious now that you've got clarity on multiple myeloma, is there potential to accelerate those filings or is it more to focus on the launch and then sort of worry about filing then?
We'll keep you posted on things. As you know, with the final data from the study where were presented in an oral presentation at ICML and we'll keep you posted on our timeline.
Got it. Great. And congrats again. Thanks.
Thank you.
Thank you. And our next question comes from the line of Eric Joseph from JP Morgan. You may begin.
Hey guys, congrats on the approval and thanks for taking the questions. My first is on, I guess, with the language and the label being fairly explicit in being indicated for a pen to refractory patient population. I'm just curious to know from your discussions with payers, whether they make a clear distinction between the pencil refractoryness versus triple class refractoryness? I guess, how heavily managed do you expect reimbursement to be to the label specifically? And I guess just thinking about launch readiness How should we be thinking about sort of the breadth of payer coverage coming out of the gate and whether there's any sort of latency to between now and your target broad, coverage and access?
Thanks.
Sure. I'll take the first one and turn it over to Perry on the reimbursement. Let's make sure we don't over read the label. The label is very explicit that says that the disease has to be refractory to 2 proteasome inhibitors, 2 imids and 1 CD38 monoclonal. It doesn't specify what those proteasome inhibitors should be, or does say what image it should be.
So we should keep that in mind. In the past, in general, physicians describe whether the patient's disease is refractory to something. And that generally suffices, and we would anticipate based on past behavior with other myeloma drugs, that could be in effect here, but we are not certain. Let me turn it over to Perry now on the reimbursement.
Yes, sure. And I think just due to the expected survival if these patients aren't treated being 3 to 5 months and the unmet need there. We don't really anticipate significant access barriers from the payers. Additionally, we've begun discussions with payers and plan to actively work with the payer community post approval to educate them on our approved label. And we put programs in place to help overcome any initial barriers to coverage, which we don't anticipate there would be a lot.
We also plan to, to submit our clinical data to the National Comprehensive Care Network, our cancer network, the NCCN for their guidelines, which we also believe would help support patient access from payers We also established our commercial leadership team early last year in 2018, and we hired our field based sales and market access teams earlier this year. Our teams are well prepared to engage and support the payer community now that we have been approved by the FDA. So we believe that we're going to be in really good shape.
Great, thanks for taking questions. That's helpful.
Thank you. And I'm showing no further questions at this time. I'd like to turn the call back to Michael Kaufman for closing remarks.
Just to thank everybody very much again for joining us post market today. And I wish you a very happy Independence Day. Enjoy. Bye bye.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a great day.