FDA OKs AstraZeneca’s Lung Cancer DrugBy
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (AZD9291) 80-mg once-daily tablets for treating patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
AZD9291 is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitizing mutations and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. ZD9291 was granted fast track, breakthrough therapy, priority review, and accelerated approval status by the FDA. In Europe and Japan, AZD9291 was granted accelerated assessment and priority review status, respectively. Interactions with regulatory authorities in the rest of the world are ongoing.
AstraZeneca has collaborated with Roche to develop the cobas EGFR Mutation Test v2 as the companion diagnostic for AZD9291. The cobas EGFR Mutation Test v2 is intended to identify a range of EGFR mutations in patients with non-small cell lung cancer, including T790M.
Osimertinib has recently been published by the World Health Organization as the proposed International Non-proprietary Name for AZD9291 and may become formally adopted during November 2015. In the US, the American Medical Association accepted osimertinib as the United States Adopted Name.