The FDA on Friday approved Astellas’ treatment for a type of gastric cancer, marketed as Vyloy (zolbetuximab). The approval came three weeks ahead of its scheduled PDUFA date of Nov. 9.
Vyloy targets a protein called Claudin18.2 that is expressed on the surface of some gastric cancer cells. The drug is now approved in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. According to the company, Claudin18.2 is expressed by 38% of patients with advanced gastric cancer.
The treatment previously won approval in Japan in March based on data from two Phase 3 clinical trials, with Astellas saying at the time that it’s the first of its class to receive approval worldwide. The drug was also authorized in Europe in September and approved by the UK in August.
Data from the Phase 3 SPOTLIGHT and GLOW trials showed statistically significant improvements in progression-free survival and overall survival compared to standard of care chemotherapy.
But Vyloy had faced hurdles in the US, including a CRL in January a week before its original decision date, after the FDA found “unresolved deficiencies” at a third-party manufacturer. The FDA gave the drug priority review back in July 2023.
Astellas did not immediately respond to a request for comment on the approval, pricing and launch details.
Other companies are also in the Claudin18.2 space, though further behind: Leap Therapeutics bought out Flame Biosciences last year with a focus on an antibody called FL-301 and a preclinical anti-Claudin18.2/CD137 bispecific. Also in 2023, AstraZeneca licensed the antibody-drug conjugate CMG901, which is in a Phase 1 trial in China for Claudin18.2-positive solid tumors, including gastric cancer.