Bristol Myers’ Breyanzi Approved by FDA for Follicular Lymphoma, Joining Gilead and Novartis in CAR-T Treatment

1. Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory follicular lymphoma.
2. Breyanzi is a chimeric antigen receptor T-cell (CAR-T) therapy, which involves genetically modifying a patient's own immune cells to recognize and attack cancer cells.
3. With this approval, Bristol Myers joins Gilead Sciences and Novartis in offering FDA-approved CAR-T therapies for follicular lymphoma, a type of non-Hodgkin lymphoma.
4. Breyanzi was previously approved for the treatment of large B-cell lymphoma, another type of non-Hodgkin lymphoma.
5. The FDA's decision was based on the results of the phase 2 TRANSCEND NHL 001 trial, which demonstrated a high response rate in patients with relapsed or refractory follicular lymphoma.
6. The approval of Breyanzi for follicular lymphoma provides another treatment option for patients who have not responded to or have relapsed after at least two prior lines of therapy.
7. CAR-T therapies have shown promising results in treating various types of cancer, but they can also cause serious side effects, such as cytokine release syndrome and neurological toxicities.
8. The cost of CAR-T therapies is typically high, which can limit access to these treatments for some patients. However, Bristol Myers has not yet announced the price of Breyanzi for follicular lymphoma.
9. The FDA's approval of Breyanzi for follicular lymphoma marks another milestone in the development of personalized cancer treatments and the use of immunotherapy to fight cancer.
10. Bristol Myers plans to continue investigating the potential of Breyanzi in other types of cancer and in combination with other therapies.