US FDA allows expanded use of J&J, Bristol Myers cell therapies

[April 06, 2024]  By Sneha S K and Bhanvi Satija

(Reuters) -The U.S. Food and Drug Administration has allowed cell therapies of Johnson & Johnson and Bristol Myers Squibb to be used for treating patients in the earlier stages of a type of blood cancer, the companies said on Friday.

Both J&J and Bristol Myers' therapies helped extend the time that patients lived without disease progression in late stage studies — more than when patients received 'standard of care' treatments, the companies said in separate statements.

The agency's decision comes after an expert panel backed the use of the therapies — J&J's Carvykti and Bristol Myers' Abecma — last month in less severely affected patients with multiple myeloma.

Guggenheim analyst Kelsey Goodwin estimated that the expanded use would add about 12,000 patients who will be eligible to use Abecma.

Goodwin estimated peak U.S. sales of $450 million from Abecma for Bristol Myers' partner 2seventybio.

Carvykti, on the other hand, could bring in as much as $7.6 billion in global peak sales for J&J and its partner Legend Biotech, Goodwin added.

Abecma and Carvykti belong to a class of treatments known as chimeric antigen receptor (CAR) T-cell therapies that work by modifying white blood cells known as T-cells to attack cancer.

A sign stands outside a Bristol Myers Squibb facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder/File Photo

The current 'standard of care' treatments include use of non CAR-T therapies in less severely affected patients.

Approved medications for the condition include J&J's Darzalex and generic cancer drugs such as pomalidomide and bortezomib.

CAR-T therapies have recently come under scrutiny from health regulators over the risk of secondary cancers.

Safety warnings were added to CAR-T therapies' prescribing information earlier this year after reports of T-cell cancers following treatments.

(Reporting by Sneha S K, Bhanvi Satija and Sriparna Roy in Bengaluru; Additional reporting by Disha Mishra in Bengaluru ; Editing by Sriraj Kalluvila, Krishna Chandra Eluri and Muralikumar Anantharaman)

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