FDA Approves New Therapies for Follicular Lymphoma, Lung Cancer

The Food and Drug Administration recently approved new biotherapies for the treatment of relapsed or refractory follicular lymphoma (FL) and extensive stage small cell lung cancer (ES-SCLC).

Lisocabtagene Maraleucel

On May 15, FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) for adults with relapsed or refractory FL who have received two or more prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.

The agency based its approval on findings from the phase 2 TRANSCEND trial; 95.7% of patients achieved a response and 73.4% achieved a complete response. The most common nonlaboratory adverse reactions was cytokine release syndrome (CRS). FDA approved lisocabtagene maraleucel with a risk evaluation and mitigation strategy due to the risk of fatal or life-threatening CRS and neurologic toxicities.

FDA previously approved lisocabtagene maraleucel to treat certain patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and various B-cell lymphomas.

Tarlatamab-dlle

FDA also granted accelerated approval to tarlatamab-dlle (Imdelltra) on May 16 for ES-SCLC with disease progression on or after platinum-based chemotherapy.

Amgen, the therapy’s manufacturer, noted that tarlatamab-dlle Is the first and only DLL3-targeting bispecific T-cell engager therapy. Tarlatamab-dlle binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells.

FDA granted accelerated approval based on findings from the phase 2 DeLLphi-301 clinical trial, in which patients who received 10 milligrams of tarlatamab-dlle every two weeks demonstrated an objective response rate (ORR) of 40% and a median duration of response of 9.7 months. The median overall survival was 14.3 months.

The tarlatamab-dlle label includes a boxed warning for CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity and embryo-fetal toxicity.