Bristol Myers’ Cancer Cell Therapy Receives FDA Green Light

The FDA has given the go-ahead for Bristol Myers Squibb’s Breyanzi – a cancer cell treatment – to be used more extensively in treating follicular lymphoma in adults. Breyanzi is now available for individuals whose cancer has returned or did not respond to prior treatments; this is the fourth approval for this groundbreaking treatment.

Follicular lymphoma usually affects people over the age of 50. The treatment of this slowly progressing cancer, which has remission and relapse intervals, becomes more difficult with each recurrence. Statistics from the U.S. show that 18.6 new cases of non-Hodgkin lymphoma are reported per 100,000 people.

Breyanzi is a chimeric antigen receptor (CAR) T-cell therapy that was first authorized in 2021 for the treatment of large B-cell lymphoma. CAR T-cell treatments are effective because they alter the genetic code of T-cells (a kind of white blood cell) so that they can specifically target and kill cancer cells. This approval from the FDA broadens the use of Breyanzi to include individuals with follicular lymphoma who have previously had two or more lines of treatment.

Bryan Campbell, who leads the commercial cell therapy department at Bristol Myers, emphasized the importance of the FDA authorization: “This expanded approval provides an option with the potential for lasting remission in a one-time infusion and a safety profile that supports administration and monitoring in a growing number of certified treatment centers across the U.S.”

Positive results from a mid-stage clinical trial supported the approval. Of the patients who had undergone at least two therapies before receiving Breyanzi, 94% went into full remission.

With this expanded authorization, Bristol Myers believes Breyanzi’s market potential will soar. To meet the increasing demand for its CAR-T medicines, the company is increasing production of Breyanzi and Abecma.

CAR-T cell treatments are modern techniques for treating cancer. These treatments provide fresh hope to those with stubborn and hard-to-manage tumors by using the body’s immune system to combat the disease. Notable cell treatments in this class that have demonstrated success in treating different kinds of blood malignancies include Yescarta by Gilead Sciences and Kymriah by Novartis.