BioCentury
DATA GRAPHICS | Data Byte

With Astellas’ Vyloy, GI tumor target CLDN18.2 gets first approval

At least 32 other programs targeting CLDN18.2, spanning six modalities, are in clinical testing for gastrointestinal tumors

April 2, 2024 12:40 AM UTC

After explosive growth that tripled the number of CLDN18.2 programs in clinical testing in three years, the drug class notched a major milestone last week, with its first regulatory approval.

Astellas Pharma Inc. (Tokyo:4503) announced on March 26 that Japan’s MHLW approved Vyloy zolbetuximab to treat CLDN18.2-positive, HER2-negative, unresectable, advanced or recurrent gastric cancer, marking the first approval for the drug class anywhere in the world.  ...