FDA Grants Priority Review To Amgen's Application For Small Cell Lung Cancer Treatment

(RTTNews) - Amgen (AMGN) Wednesday announced that the Food and Drug Administration (FDA) has granted Priority Review for the company's Biologics License Application for tarlatamab.

Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 targeting Bispecific T-cell Engager therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

"The FDA's Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "While first-line treatments often show strong responses, patients can experience aggressive recurrences and long-term survival remains a challenge. Unfortunately, for patients who relapse, there are limited treatment options, emphasizing the importance of bringing new therapies to this patient population with advanced disease."

The FDA grants Priority Review to applications for medicines that offer, if approved, significant improvements over available options or may provide a treatment option where no adequate therapy currently exists.