US FDA panel backs expanded use of J&J, Bristol Myers' CAR-T therapies

[March 16, 2024]  By Bhanvi Satija and Sneha S K

(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 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.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

"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.

(Reporting by Bhanvi Satija and Sneha S K in Bengaluru; Editing by Shailesh Kuber and Krishna Chandra Eluri)

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