Astellas Confirms FDA Acknowledgement of Zolbetuximab Resubmission

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FDA acknowledged that Astellas has resubmitted zolbetuximab for a Biologics License Application (BLA).¹ The drug is a first-in-class claudin 18.2-targets monoclonal antibody and is designed to treat various forms of gastric cancer. According to a press release issued by Astellas, FDA has set November 9, 2024, as its new target action date.

The drug had been previously submitted, but had to be resubmitted after Astellas received a complete response letter from FDA in January, 2024. While the agency did not state any issues with the clinical data, efficacy, or safety of the drug, it required resubmission due to third-party manufacturing deficiencies. Astellas resubmitted the drug on May 9, 2024, but only just announced confirmation from FDA.

In a press release, Astellas’ senior vice president and head of immuno-oncology development Moitreyee Chatterjee-Kishore, PhD, MBA, said, “Astellas is committed to introducing new targeted therapies for hard-to-treat cancers. Those living with advanced gastric or GEJ cancer often face great unmet needs, and the FDA acknowledgment of the zolbetuximab BLA resubmission brings us one step closer to offering this important treatment option to eligible patients in the U.S. facing this deadly disease."

Zolbetuximab is designed to treat locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma with tumors that are CLDN18.2 positive.

Astellas also announced that it will be presented data from 16 abstracts at ASCO 2024.² According to a press release, the company says that the volume of data it is presenting at the conference demonstrates its determination to improve cancer, especially for hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction cancers.

Tadaaki Taniguchi, MD, PhD, chief medical officer at Astellas, said in a press release, “The data at ASCO demonstrate the strength and breadth of our growing oncology portfolio and provide new insights into our transformative therapies for patients living with some of the most devastating cancers. Recent regulatory achievements mean our oncology medicines are reaching more patients than ever worldwide, and we are continuing to pursue novel targets and invest in research to improve overall survival and raise quality of life."

The company also recently announced that it is opening a new lab and office facility in southern San Francisco.³ The center, described as being state-of-the-art in a press release, will create a central location for the company’s cell and gene therapy research.

In a press release issued at the time, Astellas’ chief scientific officer Yoshitsugu Shitaka, PhD, said, “I am excited to see Astellas open a state-of-the-art West Coast Innovation Center in South San Francisco, one of the most prestigious biotechnology centers in the world. By bringing together our Bay Area businesses, including Astellas Gene Therapies, Xyphos Biosciences, Business Development, and Rx+® Business Accelerator, we will foster even greater collaboration and productivity, enabling us to advance our efforts in delivering innovative new treatments and value to patients around the world."

Sources

1. U.S. FDA Acknowledges Astellas’ Resubmission of Biologics License Application for Zolbetuximab and Sets New Action Date. Astellas. May 30, 2024. Accessed May 31, 2024. https://www.prnewswire.com/news-releases/us-fda-acknowledges-astellas-resubmission-of-biologics-license-application-for-zolbetuximab-and-sets-new-action-date-302160157.html
2. Astellas Showcases Scientific Advancements Across its Oncology Portfolio at 2024 ASCO Annual Meeting. Astellas. May 13, 2024. Accessed May 31, 2024. https://www.prnewswire.com/news-releases/astellas-showcases-scientific-advancements-across-its-oncology-portfolio-at-2024-asco-annual-meeting-302142824.html
3. Astellas Unveils New, State-of-the-Art, $90 Million West Coast Innovation Center in the South San Francisco Biotech Corridor. Astellas. May 8, 2024. Accessed May 31, 2024. https://www.prnewswire.com/news-releases/astellas-unveils-new-state-of-the-art-90-million-west-coast-innovation-center-in-the-south-san-francisco-biotech-corridor-302140046.html