AstraZeneca (LON: AZN) and HUTCHMED's Orpathys (savolitinib) has been granted conditional approval in China to treat patients with non-small cell lung cancer (NSCLC) and MET gene alterations, the companies said on Wednesday.
It “marks the first global regulatory approval for the oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI),” AstraZeneca said.
The approval by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) was based on positive results from a Phase 2 trial conducted in China in patients with NSCLC with MET gene alterations.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “This approval makes Orpathys the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio.
“We are proud that this first-ever regulatory approval of Orpathys is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal.
“Alongside HUTCHMED, we look forward to the continued development of this medicine across a range of cancers where MET alterations and amplification are drivers of tumour growth and treatment resistance.”
AstraZeneca's London-listed share price is down 0.38% on Wednesday at 8,317p, although it is up 13.59% in 2021.
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