Tuesday, April 16, 2024

FDA Rejects Gastric Cancer Drug Zolbetuximab by Astella Due to Manufacturing Concerns

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The U.S. Food and Drug Administration (FDA) has delivered a significant setback to Astellas Pharma, denying approval for the company’s promising investigational gastric cancer drug known as zolbetuximab. The Biologics License Application (BLA) rejection for this innovative drug is rooted in concerns regarding the third-party manufacturing process.

Astellas Pharma made this disappointing announcement on January 8th through a press release, where they disclosed that the FDA had issued a complete response letter (CRL). In this letter, the FDA cited “unresolved deficiencies” discovered during an inspection of a third-party manufacturing facility responsible for producing zolbetuximab. This decision was particularly untimely, as it was made just a few days before the drug’s scheduled Prescription Drug User Fee Act (PDUFA) action date, which had been set for January 12th.

Despite FDA’s Manufacturing Concerns, Astellas Remains Optimistic About Gastric Cancer Treatment

It is worth highlighting that the FDA’s concerns do not pertain to the clinical safety or efficacy of the zolbetuximab treatment. Therefore, no additional clinical data has been requested by the FDA in the wake of this rejection. Instead, the focus is solely on addressing the manufacturing issues that have come to light during the inspection process.

In response to this setback, Astellas Pharma is expressing unwavering confidence in the clinical potential of zolbetuximab. The company firmly believes that this drug can effectively address a “significant therapeutic gap” in the treatment of gastric cancer. Astellas is now actively collaborating with both the FDA and the manufacturer of zolbetuximab to expedite the resolution of the manufacturing concerns raised by the regulatory agency.

Looking back to July 2023, there had been promising developments for zolbetuximab when the FDA granted it priority review status. The BLA submission for this drug was supported by positive results from two critical Phase III clinical trials: the SPOTLIGHT (NCT03504397) study, which assessed the combination of zolbetuximab with mFOLFOX6, and the GLOW (NCT03653507) study, which investigated zolbetuximab in conjunction with the chemotherapy regimen of capecitabine and oxaliplatin (CAPOX).

Gastric Cancer

Global Interest Grows as China and Japan Assess Zolbetuximab Beyond FDA’s Decision

In addition to the FDA, regulatory authorities in China and Japan have also been actively evaluating zolbetuximab. In August 2023, the China National Medical Products Administration’s Center for Drug Evaluation (CDE) accepted a BLA for zolbetuximab, indicating interest and potential approval on a global scale. Furthermore, in June 2023, Astellas submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour, and Welfare (MHLW), indicating its ambition to introduce the drug to the Japanese market.

Zolbetuximab, a groundbreaking chimeric IgG1 monoclonal antibody specially designed to target Claudin (CLDN) 18.2 and initiate cancer cell death for gastric cancer, has been developed to serve as first-line therapy for locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with CLDN 18.2 positive tumors. While the FDA’s decision presents a challenge, Astellas Pharma remains steadfast in its commitment to bringing this potentially life-saving gastric cancer treatment to patients in need.

 

Resource: Pharmaceutical Technology, January 09, 2024

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