Karyopharm bags an upset win at the FDA as regulators OK myeloma drug despite a host of objections
Somebody high up at the FDA must really like Karyopharm $KPTI.
On Wednesday the biotech announced that the agency had stamped an OK on their application to market selinexor for multiple myeloma, cutting ahead of the late-stage results — though in an intriguing note the agency said they had a look at additional results from an ongoing study.
The approval came despite a solid majority of experts on an outside panel who voted against a quick OK, preferring to see the Phase III data first. And it arrives despite an internal review complete with a host of objections to the data delivered to back the pitch.
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