FDA Grants Label Expansion to AstraZeneca's Datroway in Lung Cancer

Key Takeaways FDA approved Datroway for EGFR-mutated NSCLC after prior systemic and EGFR-directed therapies. Approval is backed by phase II and III studies showing a 45% objective response rate with Datroway. Datroway was first approved for breast cancer, gaining two U.S. indications within six months.AstraZeneca (AZN) announced that the FDA has expanded the label of its cancer drug Datroway for a second indication — non-small cell lung cancer (NSCLC). The drug has been developed in partnership with Japan ...