Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2).
According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a first-line treatment in combination with chemotherapy for patients with unresectable or metastatic gastric or gastro-oesophageal junction cancer (GC/GEJ) who are positive for CLDN18.2 and negative for human epidermal growth factor receptor 2 (HER2).
This approval marks Vyloy’s second significant global market authorization, following its approval in Japan in March 2024. Initially, the U.S. was anticipated to be the first market to grant approval; however, Astellas received a Complete Response Letter from the FDA in January 2024 due to deficiencies in third-party manufacturing. With those issues reportedly resolved, Astellas re-filed in the U.S. in May, and the FDA has set a PDUFA date of November 9, 2024, for its decision on the resubmission.
The UK approval is based on data from two pivotal Phase III trials, GLOW and SUNLIGHT, which assessed zolbetuximab in combination with two distinct chemotherapy regimens, CAPOX and FOLFOX, compared to placebo plus the same regimens. Results indicated that zolbetuximab extended median overall survival by approximately four months relative to the placebo group.- Flcube.com
