Mar 15, 2024 - Health

Safety risks hang over CAR-T therapies for myeloma

Tina Reed

An image of the Food and Drug Administration sign outside it's headquarters. — Photo: Sarah Silbiger/Getty Images

Food and Drug Administration advisers Friday will weigh the risk of premature patient deaths from adverse events when they consider expanding the use of two CAR-T therapies for multiple myeloma.

Why it matters: CAR-T treatments have shown promise in the way they can reprogram a patient's immune cells to attack cancer cells but are pricey and have been flagged before for safety concerns.

The FDA in January required boxed warnings over an increased risk for patients developing secondary cancers.

Why it matters: While CAR-T treatments from Bristol Myers Squibb's Celgene Corp. and J&J's Janssen Biotech each improved progression-free survival in myeloma trials, FDA staff in briefing documents flagged concerns about an increased risk of early death from adverse events, not from the underlying disease.

In the BMS product, called Abecma, the rate of deaths from adverse events among patients taking the treatment was 18% over nine months compared with 11% in patients in a control arm.
In the Janssen product, called Carvykti, deaths from adverse events among those receiving the treatment was 14% over 10 months compared with 12% of those receiving the standard of care.
The advisory committee will be considering whether the benefit of expanding both to earlier stages of treatment outweighs the risks.

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Safety risks hang over CAR-T therapies for myeloma

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