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1:38 PM
Jul 03, 2019
 |  BC Extra  |  Company News

After negative panel vote, FDA approves Karyopharm's multiple myeloma drug

FDA evidently saw enough data from an ongoing confirmatory trial to grant accelerated approval to Karyopharm's Xpovio selinexor to treat relapsed or refractory multiple myeloma. During the drug's extended review, the new data added to the body of evidence Karyopharm had initially submitted seeking Xpovio's authorization.

In February, FDA's Oncologic Drugs Advisory Committee voted 8-5 in favor of delaying a decision on Xpovio's approval until data from the confirmatory Phase III BOSTON trial became available. A readout from that study is due either late this year or early next.

The agency said Wednesday it evaluated "additional information from an ongoing, randomized trial in patients with multiple myeloma" to reach its approval decision. On a conference call Wednesday afternoon, CEO Michael Kauffman said...

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