FDA AdCom recommends GSK’s anti-BCMA drug for approval 12-0 despite searing in-house review — does it matter?
The FDA may have ripped GlaxoSmithKline for the safety of its anti-BCMA drug, but that didn’t stop an advisory committee from voting 12-0 to recommend approval for the multiple myeloma treatment.
The decision is in line with the committee’s long-running preference to approve cancer drugs that show enough efficacy and not overwhelming safety concerns, with the goal of giving oncologists as many tools to work with as possible as they treat individual patients. Yet while it signaled a strong likelihood of FDA approval — and boosted GSK’s stock by a nifty 1.6% — the vote still leaves open the question of how useful the drug will ultimately be and, accordingly, how well it will sell for a company trying to claw back into the cancer therapeutics business.
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