HUTCHMED Achieves Breakthrough Therapy Designation for Savolitinib's Potential in Treating Gastric Cancer
HUTCHMED has announced a significant milestone in the field of gastric cancer treatment. The Center for Drug Evaluation under China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to savolitinib. This designation is specifically for the treatment of patients facing locally advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, where the tumors exhibit mesenchymal epithelial transition factor (MET) amplification and have not responded to at least two standard therapies.
Gastric cancer with MET amplification is often associated with a particularly challenging prognosis. HUTCHMED's ongoing registration trial builds upon several Phase II studies conducted in Asia, with a notable example being the VIKTORY study conducted in South Korea. In VIKTORY, 715 patients were enrolled and molecularly stratified, with a focus on those with MET-amplified gastric cancer. Patients exhibiting MET amplification were treated with ORPATHYS® monotherapy within the study.
Savolitinib is an orally administered, highly selective MET tyrosine kinase inhibitor. Its clinical efficacy has been demonstrated in advanced solid tumors by effectively blocking the abnormal activation of the MET receptor tyrosine kinase pathway. Such abnormal activation often occurs due to mutations (like exon 14 skipping alterations or other point mutations), gene amplification, or overexpression of the MET protein. In China, it is marketed as ORPATHYS® for treating non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations after previous systemic therapy or when chemotherapy is not suitable. Savolitinib is currently undergoing clinical development for various cancer types, including lung, kidney, and gastric cancers, both as a standalone treatment and in combination with other therapeutic approaches.
