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US FDA panel backs expanded use of J&J, Bristol Myers' CAR-T therapies
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US FDA panel backs expanded use of J&J, Bristol Myers' CAR-T therapies
Mar 15, 2024 3:47 PM

By Bhanvi Satija and Sneha S K

March 15 (Reuters) - Advisers to the U.S. health

regulator voted in favor of allowing the use of Johnson &

Johnson and Bristol Myers Squibb's cell

therapies as earlier treatments on Friday, paving the way for

their use in less severely affected patients with a type of

blood cancer.

While all 11 voting members of the panel unanimously agreed

the benefits of J&J and Legend Biotech's ( LEGN ) Carvykti

outweighed the risks of the therapy when given as an earlier

treatment, only eight voted in favor of Bristol's Abecma.

The therapies are already approved in the U.S. for multiple

myeloma patients whose cancer has returned or stopped responding

to four prior lines of treatment.

"To be able to give a one-time treatment (to patients) and

without requiring them to come back and forth is a really

important option," said panelist Mary Kwok.

The FDA's staff reviewers presented concerns about a pattern

of early deaths observed in late-stage studies of both the

therapies, which they had raised earlier this week.

Bristol, which partners with 2seventybio for

Abecma, said the deaths occurred in patients before receiving

its therapy and most were due to patients' disease worsening.

Panelists noted the time patients live after receiving

Abecma was relatively similar to those who received

standard-of-care therapy in the trial.

"The data we have now appears transient and there's no clear

benefit that earlier is better than later," said panelist Daniel

Spratt who voted against early use of Abecma.

For Carvykti, several panelists said that while the early

deaths were concerning, their cause was not immediately clear

and it seemed unlikely they were related to the therapy.

J&J said some of the early deaths occurred at a time when

patients were receiving therapy that would have helped them

bridge to Carvykti.

The FDA, which usually follows the advice of its panel but

is not bound to do so, is expected to make a decision on early

use of Carvykti by April 5.

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