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US FDA staff raise concerns over data from J&J, Bristol’s CAR-T therapies

Mar 14,2024

London: The U.S. Food and Drug Administration’s staff on Wednesday raised concerns that it was unclear if Johnson & Johnson and Bristol Myers Squibb ‘s cell therapies 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 class known as CAR-T.

“I think there is a need for these therapies as patients are relapsing earlier,” said Eric Smith from Boston’s Dana Farber Cancer Institute.

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

Carvykti and Abecma are approved by the FDA 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.

Guggenheim analyst Kelsey Goodwin said the FDA’s stance was harsher-than-expected, but expects both therapies to gain approval.

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

About 8 per cent 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 does 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.

The meeting of FDA’s independent advisers set for Friday will be closely watched by investors to understand the regulator’s view on CAR-T therapies, after recent safety concerns over the treatments.

Source: Pharma