FDA grants Priority Review for Astellas Pharma’s BLA for cancer drug

James Spargo | July 6, 2023 | News story | Research and Development Astellas Pharma, Biologics License Application, FDA, GEJ, Oncology 

Japanese pharmaceutical company Astellas Pharma has announced that the US Food and Drug Administration (FDA) has granted Priority Review for its Biologics License Application (BLA) for cancer drug zolbetuximab.

Zolbetuximab is an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2 positive.

The BLA approval came after results from the phase 3 SPOTLIGHT and GLOW trials. SPOTLIGHT evaluated zolbetuximab plus mFOLFOX6 (a combination regime including oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. GLOW compared zolbetuximab plus CAPOX (chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

For both, the primary endpoint was progression-free survival, with secondary endpoints being overall survival, objective response rate, duration of response, safety and tolerability and quality of life parameters. 

Moitreyee Chatterjee-Kishore PhD MBA, senior vice president and head of Immuno-Oncology Development at Astellas, commented: “Astellas is committed to bringing innovative therapies to patients with hard-to-treat cancers, including gastric cancer. While rare in the US, gastric cancer can be deadly when diagnosed in the late stages. The FDA’s acceptance of the BLA filing and Priority Review designation for zolbetuximab confirms the urgent therapeutic need and brings us one step closer to delivering on this commitment to patients, families and caregivers.”

James Spargo

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