04/06/2017

FDA has granted full approval for TAGRISSO® (osimertinib) for the treatment of patients with NSCLC.

The FDA has granted full approval for TAGRISSO^® (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. TAGRISSO is the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.

TAGRISSO was granted Fast Track, Breakthrough Therapy and Priority Review by the FDA, and received Accelerated Approval for this indication in 2015, based on tumor response rate and duration of response.

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