Amgen secures FDA priority review for BiTE therapy tarlatamab in SCLC
14 Dec 2023
Clinical ResultPriority ReviewPhase 2Phase 1Drug Approval
Amgen announced that the FDA granted priority review to its application seeking approval of tarlatamab for the third-line treatment of adults with advanced small-cell lung cancer (SCLC) who have had disease progression on or after platinum-based chemotherapy. The agency is expected to decide on the filing by June 12 next year.
Aggressive recurrences and poor long-term survival in patients with advanced SCLC who have progressed following platinum-based therapy “underscores the urgency to provide new treatment options'' for this patient population, remarked David Reese, executive vice president of R&D at Amgen. If approved, tarlatamab will be the first DLL3-targeting bispecific T-cell engager (BiTE) therapy for a major solid tumour.
The application is supported by findings from the Phase II DeLLphi-301 trial, presented at the European Society for Medical Oncology (ESMO) Congress earlier. The study demonstrated notable antitumour activity, durable responses, and promising survival outcomes with tarlatamab in previously treated patients with SCLC.
Series of trials under way
Tarlatamab is undergoing extensive investigation in SCLC across a series of ‘DeLLphi’ trials in various stages of development. Amgen also plans to initiate an additional Phase III study of tarlatamab in the first-line treatment of SCLC. Furthermore, a Phase Ib study, dubbed DeLLpro-300, is investigating tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.
Amgen has its hopes pinned on tarlatamab, after recent setbacks in the BiTE space, including AMG 340 in metastatic castration-resistant prostate cancer and the BCMA-targeting molecule pavurutamab.
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