HUTCHMED wins China approval for ORPATHYS in gastric cancer
- HUTCHMED (NASDAQ:HCM) received conditional NMPA approval in China for ORPATHYS® (savolitinib).
- The drug is approved for MET-amplified gastric or gastroesophageal junction adenocarcinoma after at least two prior treatments.
- Phase II results showed a 32.3% objective response rate and median progression-free survival of 4 months.
HUTCHMED (NASDAQ:HCM) received conditional approval from China’s National Medical Products Administration for ORPATHYS® (savolitinib) to treat certain advanced gastric and gastroesophageal junction cancers.
The approval applies to patients with MET amplification who have already received at least two prior systemic therapies.
The decision follows a Phase II clinical study supporting the treatment’s efficacy in this patient group.
The study reported an investigator-reviewed objective response rate of 32.3% and a disease control rate of 63.1%.
It also showed a median duration of response of 9.7 months and a median progression-free survival of 4 months.
The approval expands ORPATHYS use in China into a later-line treatment setting for a difficult-to-treat cancer type.
HUTCHMED continues to develop targeted oncology therapies focused on biomarker-driven patient populations.
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