FDA Converts Tagrisso to Full Approval in NSCLC after Confirmatory Phase III Trial

The FDA granted full approval for AstraZeneca’s Tagrisso (osimertinib) tablets for metastatic non-small cell lung cancer, converting from a 2015 accelerated approval.

Tagrisso is approved for patients testing positive for an epidermal growth factor receptor T790M mutation, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor therapy. Tagrisso is the first and only approved medicine in the U.S. indicated for NSCLC patients who have tested positive for the mutation.

The full approval was based on data from a Phase III trial where Tagrisso significantly improved progression-free survival compared to platinum-based doublet chemotherapy, with 10.1 months compared to 4.4 months.

Tagrisso had also received Fast Track, Breakthrough Therapy and Priority Review from the FDA. Its accelerated approval was based on tumor response rate and duration of response, with a blood-based companion diagnostic test for the T790M mutation approved in September 2016.