The FDA recently cleared Johnson & Johnsons’ Carvykti and Abecma by Bristol Myers Squibb for earlier treatment via expanded approval. The two therapies target BCMA, a protein found on malignant B cells in multiple myeloma patients. These patients often relapse or find that their cancer has become resistant, and they must switch to another regimen.
Yet Agency reviewers raised concerns about increased rates of death in early Phase 3 trials for both drugs. The deaths were attributed to adverse events rather than disease progression. The FDA appeared to have somewhat more concern about Abecma than Carvykti.
Abecma is co-marketed by 2seventy Bio and is available to multiple myeloma patients who have received a minimum of two drug regimens.
Carvykti, developed by J&J and Legend Biotech, may be administered after the patient has been given one previous therapy including a proteasome inhibitor and immunomodulatory drug. In addition, the patient’s disorder should be resistant to the Revlimid drug.
FDA Safety Concerns
CAR-T therapies are built individually from the patient’s immune cells. Admittedly, the manufacturing is challenging. Trial results suggest that both Carvykti and Abecma reduced the risk of death or disease progression when comparing current regimens. However, safety concerns that were raised by the FDA put its approvals in question.
The FDA sought advice from an expert committee and found that the benefits of both drugs were sufficiently convincing. The vote in favor of the two drugs was 11-0 favoring Carvytki and 8-3 supporting Abecma.
The approval was granted three weeks after FDA advisers decided that the benefits of treating the disease earlier outweighed potential risks.
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Last modified: May 7, 2024
