FDA Full Approval for Tagrisso in Lung Cancer

FDA has granted full approved to an AstraZeneca NDA for Tagrisso (osimertinib) 80mg once-daily tablets for treating patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer. In 2015, FDA gave accelerated approval to the therapy for those whose disease has progressed on or after an EGFR tyrosine kinase inhibitor therapy.

The full approval decision was based on data from the randomized, Phase 3 AURA3 trial, in which the drug “significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing 10.1 months of median PFS compared to 4.4 months from chemotherapy,” the company says. “Additionally, in a post-hoc subgroup analysis of patients with measurable central nervous system (CNS) lesions, Tagrisso demonstrated an objective response rate (ORR) of 57%... compared to 25% ORR from chemotherapy.”