Karyopharm’s Selinexor: US FDA Unconvinced By Efficacy In Single-Arm Trial
Oncologic Drugs Advisory Committee will consider whether approval for Karyopharm’s proposed refractory myeloma therapy selinexor should await results from an ongoing Phase III randomized trial.
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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.
The latest drug development news and highlights from our US FDA Performance Tracker.
Immediate interaction with US FDA after stressful advisory committee facilitated accelerated approval in fourth-line myeloma, company says. Four different dosing regimens will be priced at $22,000 for four weeks.