Shares of US drugmaker Karyopharm Therapeutics (Nasdaq: KPTI) leapt more than 36% to $8.90 by close of trading on Wednesday, after it announced that the US Food and Drug Administration had granted accelerated for its blood cancer drug Xpovio (selinexor). The stock gained a further 5.2% to $9.36 in after-hours trading.
The FDA granted approval for selinexor in combination with dexamethasone for 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.
“While there is no cure for multiple myeloma, there are FDA-approved treatments to target the cancer and slow down the spread of the disease. Sadly, often over time, patients can exhaust all available treatments and still see their disease progress,” said Dr Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today we approved a treatment under our accelerated approval program that provides a treatment option for patients with multiple myeloma with no available therapy,” he added.
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