US FDA expands use of Bristol's cell therapy to treat rare blood cancer

By Bhanvi Satija and Sneha S K

(Reuters) -Bristol Myers Squibb said on Thursday the U.S. FDA had allowed expanded use of its cell therapy for an aggressive and rare type of blood cancer, making it the third approval for the treatment this year.

The therapy, Breyanzi, was approved for patients with mantle cell lymphoma (MCL) who had stopped responding to previous therapies or experienced a relapse.

Every year about 4,000 people in the United States are diagnosed with MCL, which starts in the white blood cells and spreads to other parts of the body. It is more common in men and older adults.

The expanded approval for Bristol's drug is based on data from a study that showed it helped clear all signs of cancer in 67.6% of MCL patients who had previously received two or more treatments.

Breyanzi belongs to a class of treatments known as CAR-Ts and works by modifying white blood cells or T-cells to attack cancer. It is also approved for use in treatment of other types of blood cancers including large B-cell and follicular lymphoma.

Bristol expects the addressable market for Breyanzi to roughly double after the recent approvals.

To cater to higher demand arising from the approvals, the company is working on expanding its manufacturing capacity for its CAR-T therapies - Breyanzi and Abecma.

"We continue to proactively expand our capacity to support increased patient demand and now have more than 100 treatment centers throughout the country certified to administer Breyanzi," said Lynelle Hoch, president, Cell Therapy Organization at Bristol.

Hoch said the company would take bookings for the new indication within a day of the approval.

Breyanzi, like other CAR-T therapies, comes with a serious warning about the risk of secondary malignancies, or cancers, in patients who use the drug.

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