Karyopharm Selinexor Approval Likely Awaits BOSTON Trial, But US FDA Promises To Move Quickly
Oncologic Drugs Advisory Committee says Karyopharm’s multiple myeloma therapy is not ready for approval based on a single arm study. US FDA says it will move quickly when randomized trial is done.
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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.
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.
It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.