MedCity News October 21, 2024
The FDA approved Astellas’s Vyloy as a treatment for advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for a protein called claudin 18.2. It’s the first FDA-approved therapy for this target.
An Astellas Pharma drug designed to address a novel target has landed a highly anticipated FDA approval for a rare type of gastrointestinal cancer, making it the first therapy in a new class of oncology drugs.
The regulatory decision announced Friday covers the first-line treatment of adults with advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma. These cancers must express the cancer protein claudin 18.2 (CLDN18.2), the target of the Astellas antibody, zolbetuximab. The Japanese pharmaceutical company will market the new drug under the brand name...
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