HUTCHMED Receives Approval for ORPATHYS® and TAGRISSO® Combination in Lung Cancer Treatment
Tuesday, July 01, 2025
HUTCHMED has received approval from the China National Medical Products Administration (NMPA) for the combination therapy of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib).
Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for 80–85% of all cases. A large proportion of NSCLC patients in Asia have EGFR mutations, and MET amplification is recognised as a common resistance mechanism following EGFR TKI therapy.
ORPATHYS® has already been approved in China for adult patients with locally advanced or metastatic NSCLC harbouring MET exon 14 skipping alterations. It continues to be studied in combination therapies across other tumour types including lung, kidney, and gastric cancers.
TAGRISSO® has been widely used globally, with clinical trials supporting its effectiveness across different stages of EGFR-mutated NSCLC. It is currently being assessed in further studies, including global and China-specific Phase III trials such as SAFFRON, SANOVO, and the previously mentioned SACHI trial.
ORPATHYS® is a selective MET inhibitor, while TAGRISSO® is a third-generation EGFR TKI. The regulatory approval was based on positive results from the SACHI Phase III trial (NCT05015608), which showed that the combination significantly improved progression-free survival compared to chemotherapy.
The combination is now approved for patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) who have developed MET amplification after disease progression on first-line EGFR tyrosine kinase inhibitor (TKI) therapy.
The approval also triggered a milestone payment of US$11 million from AstraZeneca, which markets both medicines in China. This marks the third indication approved in China for ORPATHYS®.
The approval of this combination in China provides a chemotherapy-free treatment option for a subset of NSCLC patients who have limited alternatives following progression on initial targeted therapies.
Source: hutch-med.com
