AstraZeneca announced the launch of Tagrisso (osimertinib) 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, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso was designated as a Breakthrough Therapy and approved by the Food and Drug Administration (FDA) on November 13, 2015.
Tagrisso is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitizing mutations (EGFRm), and T790M, a genetic mutation responsible to EGFR-TKI treatment resistance. Its approval was based on two multicenter, single-arm, open-label clinical trials in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI (Study 1 and 2).
Tagrisso is available immediately at Biologics as 40mg and 80mg tablets in 30-count bottles. Physicians may submit prescriptions to Biologics via phone [(800) 850-4306, option 2], fax [(800) 823-4506] or eScribe.