Hutchmed (China) announced that the Center for Drug Evaluation of China's National Medical Products Administration has included the combination therapy of Vorasidenib® (Savolitinib) and Tarsiva® (Osimertinib) in the category of breakthrough therapies. This therapy is used to treat patients with locally advanced or metastatic non-small cell lung cancer positive for EGFR mutations with MET amplification, who have experienced disease progression after treatment with EGFR inhibitors. This designation may help accelerate the development and review process of this innovative therapy to meet patient needs more quickly.Currently, this combination therapy is being evaluated in the SACHI China Phase III study, comparing its efficacy and safety with standard platinum-based doublet chemotherapy. The primary endpoint of the study is progression...Show More

Hutchmed (China) announced that the Center for Drug Evaluation of China's National Medical Products Administration has included the combination therapy of Vorasidenib® (Savolitinib) and Tarsiva® (Osimertinib) in the category of breakthrough therapies. This therapy is used to treat patients with locally advanced or metastatic non-small cell lung cancer positive for EGFR mutations with MET amplification, who have experienced disease progression after treatment with EGFR inhibitors. This designation may help accelerate the development and review process of this innovative therapy to meet patient needs more quickly.Currently, this combination therapy is being evaluated in the SACHI China Phase III study, comparing its efficacy and safety with standard platinum-based doublet chemotherapy. The primary endpoint of the study is progression-free survival (PFS). MET abnormalities are a major mechanism of resistance to EGFR TKIs, and approximately 15-50% of patients experiencing disease progression after treatment with Osimertinib show MET abnormalities.Vorasidenib® has received conditional approval in China for the treatment of non-small cell lung cancer patients with MET exon 14 skipping mutations and has been included in the national medical insurance drug list. Hutchmed (China) is collaborating with AstraZeneca to develop Vorasidenib®, responsible for marketing authorization, production, and supply in China, while AstraZeneca is responsible for global commercialization.