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HomeNews UpdateFDA flags J&J, Bristol’s CAR-T therapies

FDA flags J&J, Bristol’s CAR-T therapies

US Food and Drug Administration (FDA) staff have expressed concern about Johnson & Johnson’s and Bristol Myers Squibb’s cell therapies, saying it is unclear whether these would benefit blood cancer patients when given as early treatments.

Regulatory approval for the therapies as earlier treatments could expand their use to a larger subset of blood cancer patients who are less sick than those treated with multiple therapies. The therapies – J&J’s Carvykti and Bristol’s Abecma – belong to the CAR-T class.

FDA’s staffers pointed to a pattern of early deaths in late-stage trials of the therapies, saying this raised questions over the effectiveness of the treatments in extending the time patients live after receiving them.

Reuters reports that Carvykti and Abecma are approved to treat patients with multiple myeloma who have received at least four prior lines of treatment. J&J partners with Legend Biotech for Carvykti, while 2seventy bio is Bristol’s partner for Abecma.

In late-stage studies, both the treatments helped extend the time patients live before their disease begins to worsen.

About 8% of trial patients died after receiving Carvykti or Abecma – a proportion higher than those being treated with standard-of-care therapies.

While data for Carvykti do not clearly establish the need for an additional trial, further overall survival data from Abecma may not be sufficient to overcome the risk of early deaths, the reviewers said.

J&J said it remained confident in the clinical profile of Carvykti.


Reuters article – US FDA staff raise concerns over data from J&J, Bristol’s CAR-T therapies (Open access)


See more from MedicalBrief archives:


FDA probes safety of CAR-T therapies


FDA adds compulsory boxed warning for CAR-T therapy


Decade-long leukaemia remissions with CAR T-cell therapy – Landmark study




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