FDA Accepts Application for Zolbetuximab in Gastric, GEJ Cancers

The FDA will speed up the review of zolbetuximab for gastric and GEJ cancers.

The Food and Drug Administration (FDA) accepted and granted a priority review for a biologics license application regarding zolbetuximab for first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors.

Zolbetuximab is a monoclonal antibody that targets CLDN18.2, a protein that serves as a biomarker in gastric and gastroesophageal junction cancers. If the FDA approved this novel drug, it would be the first monoclonal antibody to target this specific biomarker in the U.S., according to a press release from Astellas, the manufacturer of zolbetuximab.

“Astellas is committed to bringing innovative therapies to patients with hard-to-treat cancers, including gastric cancer,” Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development for Astellas, said in the release. “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 biologics license application is based on findings from the SPOTLIGHT and GLOW trials. In particular, patients enrolled in the SPOTLIGHT trial were treated with zolbetuximab plus mFOLFOX6 (a combination treatment with leucovorin, oxaliplatin and fluorouracil) or placebo, whereas patients in the GLOW trial were treated with either zolbetuximab plus a chemotherapy regimen with oxaliplatin and capecitabine (a regimen known as CAPOX) or placebo plus CAPOX.

Of note, in both trials, an estimated 38% of patients had tumors that were CLDN18.2-positive, according to the release. Results from both trials demonstrated a benefit in progression-free survival (the time during and after treatment when a patient lives without disease worsening) with a zolbetuximab-based treatment.

Approximately 26,500 people in the United States will be diagnosed with gastric cancer, according to the company’s release, and 11,130 are estimated to die from the disease in 2023. Patients are often diagnosed with gastric cancer in advanced or metastatic stages since early-stage gastric cancer symptoms can coincide with common stomach-related issues. The release noted that the five-year relative survival rate for patients with metastatic gastric cancer is 6.6%.

“While rare in the U.S., gastric cancer can be deadly when diagnosed in the late stages,” Chatterjee-Kishore said in the release.

With a biologics license application, a pharmaceutical company — in this case, Astellas — is requesting permission from the FDA to make a therapy available for patients in the U.S., according to the Agency’s website. The priority review granted by the FDA means that the agency must make a decision within six months, compared with the 10 months granted under standard review.

“A priority review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications,” according to the FDA’s website.

The target action date set by the FDA for this drug’s application is Jan. 12, 2024, according to the press release.

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