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AstraZeneca, Hutchmed's Lung Cancer MET Inhibitor Approved in China

NEW YORK – China's National Medical Products Administration (NMPA) has granted conditional approval to Hutchmed and AstraZeneca's MET inhibitor savolitinib as a treatment for non-small cell lung cancer patients who have progressed on systemic therapy, are unable to receive chemotherapy, and harbor MET exon 14 skipping alterations in their tumors.

The NMPA granted priority review to savolitinib and the conditional approval marks the first regulatory action on the drug, which Hong Kong-headquartered Hutchmed is co-developing with AstraZeneca. The two firms inked a global licensing agreement a decade earlier, under which Hutchmed is responsible for manufacturing and supplying savolitinib, and AstraZeneca is commercializing the drug globally including in China.

"Our collaboration with AstraZeneca in 2011 has been an important driver in the development of this novel targeted oncology drug, involving both a China-based biotech and a global pharma company," Hutchmed CEO Christian Hogg said in a statement. "This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumors.”

The NMPA approved the drug based on the objective response and disease control rates seen among NSCLC patients with MET exon 14 skipping mutations who received the drug in a Phase II trial conducted in China. The continued availability of the drug is contingent upon the drug successfully demonstrating safety and efficacy in a confirmatory trial. Around 3 percent of NSCLC patients harbor MET exon 14 skipping alterations.

AstraZeneca is also exploring savolitinib in combination with its EGFR inhibitor osimertinib (Tagrisso) in the TATTON and SAVANNAH trials, which involve patients with EGFR-mutated and MET-amplified NSCLC who have progressed on an earlier EGFR inhibitor.