The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting response rate and duration of response (DoR), and is subject to confirmation from subsequent trials.
Imdelltra is designed to direct a patient’s T-cells to target DLL3-expressing tumor cells, which are typically found in SCLC. The drug’s unique mechanism of action makes it a potentially valuable treatment option for patients with ES-SCLC.
As detailed in the press release, the drug’s label carries warnings for cytokine release syndrome (CRS) and neurologic toxicity, among other potential adverse effects, indicating the need for careful patient monitoring.- Flcube.com
