Tarlatamab FDA Approved for Treatment of Extensive Stage Small Cell Lung Cancer

Tarlatamab, developed by Amgen in the United States, is a first-of-its-kind bispecific delta-like ligand 3 (DLL3)-directed CD3 T cell engager that can bind to DLL3 expressed on the surface of cells (including tumor cells) and CD3 expressed on the surface of T cells. On May 16, 2024, Tarlatamab was approved by the US FDA for the first time for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy.

Tarlatamab (Tarlatamab) approved indications

1. Small cell lung cancer

Tarlatamab (Tarlatamab) is suitable for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy.

2. Conditions for approval

Talatamab (Tarlatamab) has obtained the qualification for accelerated approval based on the significant response rate and durable response effect demonstrated in clinical studies. Tarlatamab Continued approval for the indication may be contingent on verification and description of clinical benefit in confirmatory trials.

About Tarlatamab

1. Tarlatamab (Tarlatamab)

Tarlatamab (Tarlatamab) is the first and only bispecific T cell engager therapy targeting DLL3, which can activate the patient's own T cells to attack tumor cells expressing DLL3.

2. Important information

Tarlatamab carries a boxed warning for cytokine release syndrome and neurological toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions related to Tarlatamab include cytopenias, hepatotoxicity, hypersensitivity reactions, and embryo-fetal toxicity. To date, no carcinogenicity or genotoxicity studies have been conducted on Tarlatamab.