Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.
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The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions
Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.
Bumpy EU Review Ends Well For Selinexor Filing
Karyopharm says its treatment for patients with refractory multiple myeloma could become its first product to be approved in Europe.
EU Crunch Time For Two Drugs That Lost Their Fast-Track Status
Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.