Regulation
GSK first across finish line in closely watched BCMA race
Despite toxicity concerns, FDA approved GSK’s BCMA-targeted antibody-drug conjugate Blenrep late Wednesday, making it the first in a new class of drugs for multiple myeloma.
The accelerated approval for GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) didn’t come without strings attached. Blenrep belantamab mafodotin-blmf’s label includes a warning for ocular toxicities and a Risk Evaluation and Mitigation Strategy (REMS). The therapy is approved for patients with relapsed and refractory MM who progressed on an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The approval follows a unanimous recommendation from FDA’s Oncologic Drugs Advisory in July, which discussed the risk of vision loss. In the pivotal Phase II DREAMM-2 study, Blenrep led to an overall response rate of 31% in heavily pretreated MM patients, though 72% experienced some degree of keratopathy (see “GSK Maintains Lead in BCMA Race”).
A GSK spokesperson told BioCentury that the drug is expected be available to patients before the end of August at a wholesale acquisition cost (WAC) of $8,277 per vial, for an estimated monthly cost of $23,900 based on an average patient weight of 80kg.
Next up before regulators: bluebird bio Inc. (NASDAQ:BLUE) and Johnson & Johnson (NYSE:JNJ), which are eyeing regulatory submissions this year for their respective anti-BCMA CAR T cell therapies (see “BCMA Pipeline”).
Targets
BCMA (TNFRSF17; CD269) - Tumor necrosis factor receptor superfamily 17
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