Mar 15, 2024 - Health

Safety risks hang over CAR-T therapies for myeloma

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.

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.
Go deeper