Amgen has received the US Food and Drug Administration (FDA) priority review for its biologics licence application (BLA) for tarlatamab to treat advanced small cell lung cancer (SCLC).

The regulator accepted the BLA and is expected to provide a decision on the approval for the therapy on 12 June 2024 under the terms of the Prescription Drug User Fee Action Act.

An investigational bispecific T-cell engager (BiTE) therapy that acts on delta-like ligand 3 (DLL3), tarlatamab is being assessed to treat adults with advanced SCLC who have progressed on or following platinum-based chemotherapy. 

The company filed the BLA based on the findings from the Phase II DeLLphi-301 clinical trial of tarlatamab in advanced SCLC patients. 

Treatment with the therapy offered antitumour activity with lasting response and favourable survival outcomes.

Its safety profile was in line with that reported in the Phase I trial.

Amgen research and development executive vice-president David Reese stated: “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. 

“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, emphasising the importance of bringing new therapies to this patient population with advanced disease.”

Tarlatamab received FDA breakthrough therapy designation in October 2023. 

It is currently being analysed in three Phase Ib studies, DeLLpro-300, DeLLphi-302 and DeLLphi-303, and two Phase III studies, DeLLphi-304 and DeLLphi-306.

DeLLphi-302 is assessing tarlatamab plus an anti-PD-1 therapy in second-line or later SCLC while DeLLphi-303 is evaluating the therapy plus standard-of-care treatments in first-line SCLC.

DeLLphi-304 is investigating tarlatamab single agent against standard-of-care chemotherapy in second-line SCLC patients.

Tarlatamab treatment after chemoradiotherapy in earlier settings of SCLC is being analysed in DeLLphi-306, while DeLLpro-300 is assessing it in de novo or treatment-emergent neuroendocrine prostate cancer.

The company also intends to commence a Phase III trial of tarlatamab to treat SCLC in a first-line setting.