AstraZeneca Receives FDA Approval for Savolitinib in MET Exon 14-Skipping NSCLC

AstraZeneca today announced that the FDA has approved Orpathys (savolitinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer whose tumors have MET exon 14 skipping alterations. In the Phase 2 SAVANNAH trial, savolitinib demonstrated an overall response rate of 49% in patients with MET exon 14-skipping NSCLC. The safety profile was manageable with peripheral edema and nausea being the most common adverse events. This approval provides a new targeted treatment option for this molecularly defined NSCLC subgroup.