FDA Rejects AZN's Saphnelo SubQ Formulation, Priority Tag to Datroway

Key Takeaways FDA granted priority review to AZN's Datroway sBLA for unresectable or metastatic TNBC, with a Q2 2026 target.AZN's Datroway already has approvals in breast and lung cancer and is being studied across multiple cancers.The FDA issued a CRL for AZN's Saphnelo SC. AZN has resubmitted data and expects a U.S. decision in H1 2026.AstraZeneca (AZN) and its Japan-based partner Daiichi Sankyo announced that the FDA has accepted and granted priority review to their supplemental biologics license applica ...