Karyopharm Gets Accelerated FDA Approval For Myeloma Drug

Shares of Karyopharm Therapeutics Inc. ( (NASDAQ:KPTI) ) rallied 36% after the FDA granted accelerated approval to oral Xpovio (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.Selinexor is the first FDA-approved medication for this indication. Shares of the company have increased 111% year to date compared with the industry’s growth of 11.8%.

The approval was supported by data from the phase IIb STORM study in patients with RRMM. In the study,122 patients were treated with selinexor 80 mg in combination with dexamethasone 20 mg on days 1 and 3 of every week. A pre-specified subgroup analysis of 83 patients, whose disease was refractory to prior treatments, showed that the benefit-risk ratio was greater in the more heavily pretreated population than the overall trial population. The overall response rate, which served as the basis for Xpovio’s accelerated approval, was 25.3% in this subgroup. The subgroup included 1 stringent complete response, no complete responses, 4 very good partial responses and 16 partial responses. The median time to first response for these patients was 4 weeks and the median duration of response was 3.8 months, per the data.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory study. The ongoing, randomized phase III BOSTON trial evaluating Xpovio in combination with Velcade (bortezomib) and low-dose dexamethasone will serve as the confirmatory study.

Karyopharm expects Xpovio to become commercially available in the United States on or before Jul 10, 2019. A Marketing Authorization Application for the drug is also currently under review by the European Medicines Agency.

We remind investors that last month, Johnson & Johnson (NYSE:JNJ) announced that its subsidiary Janssen received approval from the FDA for label expansion of its blockbuster drug, Darzalex, to treat newly diagnosed multiple myeloma (“MM”) patients, who are ineligible for autologous stem cell transplant (“ASCT”). The approval is for Darzalex in combination with Celgene’s (NASDAQ:CELG) Revlimid (lenalidomide) and dexamethasone (Rd). The drug is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as frontline and relapsed settings.

These include combination studies with other cancer drugs like Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Tecentriq, Bristol-Myers’ Opdivo and Amgen’s Kyprolis.

Karyopharm Therapeutics Inc. Price

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Karyopharm currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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