Amgen announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved its therapy tarlatamab, to be marketed under the name Imdelltra, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
Imdelltra is a DLL3-targeting T-cell engager therapy indicated for the treatment of adults for the treatment of adult patients with ES-SCLC with disease progression who are being or have been treated with platinum-based chemotherapy. In a statement, Amgen noted that it activates the patient's own T cells to attack DLL3-expressing tumor cells.
According to the firm, Imdelltra received accelerated approval based on results observed in the phase II DeLLphi-301 clinical trial that evaluated IMDELLTRA in patients with SCLC who had failed two or more prior lines of treatment. Amgen noted that continued approval for this indication may require verification of its clinical benefits in a confirmatory trial.
In addition, the Imdelltra label includes a boxed warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.
