The FDA issued a complete response letter to Astellas this week, for the drugmaker's BLA for zolbetuximab, targeting advanced gastric or gastroesophageal junction adenocarcinoma.
Citing unresolved deficiencies in a third-party manufacturing facility, the FDA rejected the BLA, which had a January 12, 2024 regulatory action date.
Astellas is now collaborating with the agency and the manufacturer to promptly address the identified issues. Moitreyee Chatterjee-Kishore, senior VP of Immuno-Oncology Development at Astellas, expressed confidence in zolbetuximab's clinical profile and a commitment to resolving the FDA's concerns. Ongoing regulatory reviews for the drug in Japan, Europe and China remain unaffected.
While the drugmaker said that the setback is expected to have limited impact on Astellas' financial results for the fiscal year ending March 31, 2024, the drugmaker will continue to investigate the chimeric IgG1 monoclonal antibody targeting claudin 18.2 for gastric and gastroesophageal junction cancers.
Tokyo-based Astellas picked up zolbetuximab back in Oct. 2016 in its $1.4 billion acquisition of German biotech, Ganymed Pharmaceuticals. In 2022, Astellas announced positive topline results from the phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil).
The drug is Astellas’ most valuable R&D asset, with 2028 sales forcasted at $522 million.