FDA approves Astellas’ Vyloy

The US Food and Drug Administration has approved Vyloy (zolbetuximab-clzb), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine and platinum-containing chemotherapy, from Japanese drug major Astellas Pharma (TYO: 4503).

Vyloy is authorized for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.

As a result, Vyloy becomes the first US-approved anti-CLDN18.2 drug. The transmembrane protein has become a red-hot target in the oncology. Scientists believe that many people with this type of cancer could benefit from a Claudin 18.2-targeting treatment, with other firms including the UK’s AstraZeneca (LSE: AZN), Elevation Oncology (Nasdaq: ELEV) and China’s Zai Labs (HKEX: 9688) following the same approach.