Amgen (NASDAQ: AMGN) has reported that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for tarlatamab and granted Priority Review. Tarlatamab is an investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy designed for treating advanced small cell lung cancer (SCLC) in adult patients who have experienced disease progression after platinum-based chemotherapy.

The Priority Review designation underscores the need for new treatment options for patients with advanced SCLC who have relapsed following platinum-based chemotherapy. According to David M. Reese, M.D., Executive Vice President of Research and Development at Amgen, the urgency is crucial due to the limited options for patients in advanced stages.

Priority Review is granted to medicines that, if approved, offer significant improvements over existing options or may address situations where no adequate therapy currently exists. The Prescription Drug User Fee Action (PDUFA) date for tarlatamab is set for June 12, 2024, based on the Priority Review designation.

The BLA submission is supported by Phase 2 results from the DeLLphi-301 clinical trial, focusing on patients with advanced SCLC experiencing disease progression after platinum-based chemotherapy. The study's outcomes, presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine, demonstrated antitumor activity, durable response, and promising survival outcomes in previously treated SCLC. The safety profile aligned with findings from the Phase 1 trial.

Tarlatamab is undergoing investigation in various studies, including DeLLphi-302, DeLLphi-303, DeLLphi-304, DeLLphi-306, and DeLLpro-300. These studies explore tarlatamab in different settings and combinations, reflecting Amgen's commitment to addressing the diverse needs of patients with SCLC.

In October, tarlatamab received Breakthrough Therapy Designation from the FDA and is being reviewed under the Project Orbis framework and Real Time Oncology Review (RTOR). Project Orbis facilitates the simultaneous submission of oncology products among certain countries, streamlining the review process.

Small Cell Lung Cancer (SCLC) is a highly aggressive tumor with limited survival rates, making the development of effective treatments crucial. Tarlatamab, engineered to bring a patient's T cells in proximity to SCLC cells, represents a promising approach, targeting DLL3, which is prevalent in SCLC cells.

Amgen's comprehensive tarlatamab development program includes the DeLLphi and DeLLpro clinical trials, evaluating the therapy's efficacy in various SCLC and neuroendocrine prostate cancer settings. The Phase 1 and Phase 2 studies have shown promising response rates and manageable safety profiles, supporting the potential of tarlatamab as a treatment option for advanced SCLC.

 

Source: prnewswire.com

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