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US FDA allows J&J, Bristol Myers cell therapies as early cancer treatments (April 5)
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US FDA allows J&J, Bristol Myers cell therapies as early cancer treatments (April 5)
Apr 8, 2024 3:05 AM

By Sneha S K and Bhanvi Satija

April 5 (Reuters) - The U.S. Food and Drug

Administration has allowed the cell therapies of Johnson &

Johnson and Bristol Myers Squibb to be used as

earlier lines of treatments in patients with 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 ( LEGN ), 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.

The current 'standard of care' treatments include the 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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