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)