RARE Daily

U.S. FDA Grants Priority Review for Astellas’ Therapy for the Treatment of Rare Gastric Cancers

July 6, 2023

Rare Daily Staff

The U.S. Food and Drug Administration has accepted and granted Priority Review for Astellas Pharma’s Biologic License Application for zolbetuximab for first-line treatment of patients with certain gastric cancers.

Zolbetuximab is a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of January 12, 2024. The FDA reviewed the application under its Real-Time Oncology Review program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

In the U.S., it is estimated that 26,500 people will be diagnosed with gastric cancer and 11,130 will die from the disease in 2023. Early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, often resulting in gastric cancer diagnosis in the advanced or metastatic stage, or once it has spread from the tumor’s origin to other body tissues or organs. The five-year relative survival rate for patients at the metastatic stage is 6.6 percent.

“While rare in the U.S., gastric cancer can be deadly when diagnosed in the late stages,” said Moitreyee Chatterjee-Kishore, senior vice president and head of Immuno-Oncology Development, Astellas. “The FDA’s acceptance of the Biologics License Application 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.”

The BLA is based on results from the phase 3 SPOTLIGHT and GLOW clinical trials. The SPOTLIGHT study evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. The GLOW study evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

In both SPOTLIGHT and GLOW, approximately 38 percent of patients screened for the trials had tumors that were CLDN18.2-positive (≥75 percent of tumor cells with moderate-to-strong membranous CLDN18 staining intensity), as determined by a validated immunohistochemistry assay.

Photo: Moitreyee Chatterjee-Kishore, senior vice president and head of Immuno-Oncology Development, Astellas

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