FDA approves Breyanzi CAR-T for follicular lymphoma
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The FDA granted accelerated approval to lisocabtagene maraleucel for treatment of adults with relapsed or refractory follicular lymphoma who received at least two prior lines of systemic therapy.
Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) — often called liso-cel — is a CD19-directed chimeric antigen receptor T-cell therapy.
The agent already had been approved in the United States for treatment of adults with relapsed or refractory large B-cell lymphoma who received at least one prior therapy, as well as treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
The FDA based the new indication on results of the single-arm phase 2 TRANSCEND-FL trial, which included adults with relapsed or refractory follicular lymphoma. All study participants had received at least two lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
Eligible participants had adequate bone marrow function to receive lymphodepleting chemotherapy, and they had ECOG performance status of 0 or 1.
The efficacy population included 94 patients with PET-positive disease at baseline or after bridging therapy.
Patients received a single dose of lisocabtagene maraleucel 2 to 7 days after completion of lymphodepleting chemotherapy, and all had at least 9 months of follow-up from first response.
Overall response rate and duration of response served as the primary efficacy outcomes.
Researchers reported an ORR of 95.7% (95% CI, 89.5-98.8). Median duration of response had not been reached (95% CI, 18.04 to not reached) after median follow-up of 16.8 months.
Nonlaboratory adverse reactions that occurred among at least 20% of study participants included cytokine release syndrome, headache, musculoskeletal pain, fatigue, constipation and fever.
The FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy due to risk for fatal or life-threatening CRS and neurologic toxicities.
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