NEW YORK – Hutchmed on Thursday said China's National Medical Products Administration has accepted its supplemental new drug application seeking approval for the MET kinase inhibitor Orpathys (savolitinib) as a first-line treatment for patients with advanced non-small cell lung cancer with MET exon 14 skipping alterations.
The drug, which is marketed in China by AstraZeneca under a 2011 licensing agreement, is already conditionally approved in the country for patients with MET exon 14 skipping-mutated NSCLC who have progressed on prior systemic therapy or who are unable to receive chemotherapy.
The application is supported by data from a Phase IIIb trial in which 62.1 percent of treatment-naïve patients had an objective response to Orpathys. The disease control rate was 92 percent, and the median duration of response was 12.5 months. The median progression-free survival was 13.7 months, and the median overall survival was not reached after a median follow-up of 20.8 months.
In previously treated patients in that study, the overall response rate on Orpathys was 39.2 percent, the disease control rate was 92.4 percent, and the median duration of response was 11.1 months. These patients had a median progression-free survival of 11 months, and median overall survival data were not mature at a median follow-up of 12.5 months.