FDA Broadens Breyanzi’s Follicular Lymphoma Indication

The US Food and Drug Administration (FDA) has granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics /Bristol Myers Squibb) for adults with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy.

The approval broadens the use of the CAR T-cell therapy for follicular lymphoma. Previous approval was limited to relapsed/refractory grade 3B disease. Lisocabtagene maraleucel also carries relapsed/refractory B-cell lymphoma and lymphocytic leukemia indications.

The new approval was based on the phase 2 single-arm TRANSCEND FL trial in 94 patients with relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.

Adequate bone marrow function and a performance score of 0-1 were required.

Patients received a single dose 2-7 days after completing lymphodepleting chemotherapy.

The overall response rate was 95.7%. The median duration of response was not reached after a median follow-up of 16.8 months.

The most common nonlaboratory adverse events, occurring in at least 20% of patients, were cytokine release syndrome, headache, musculoskeletal pain, fatigue, constipation, and fever.

Lisocabtagene maraleucel is available only through a Risk Evaluation and Mitigation Strategy program due to the risk for fatal cytokine release syndrome and neurologic toxicities.

A single treatment is almost a half million dollars, according to drugs.com.
 

A version of this article appeared on Medscape.com.