Regulatory Affairs

FDA approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC

PBR Staff Writer Published 03 April 2017

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Tagrisso (osimertinib) 80mg once-daily tablets to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

The approval has been granted to treat patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy.

Tagrisso 40mg and 80mg once daily oral tablet were approved in around 45 countries such as the US, EU, Japan and China

It is a third generation and irreversible EGFR tyrosine kinase inhibitor developed to suppress both EGFR sensitising and EGFR T790M resistance mutations. It will also be used to carry out activity in the central nervous system (CNS). 

The approval was based on data from the randomised, Phase III AURA3 study, in which Tagrisso significantly improved progression-free survival (PFS) compared to platinum-based doublet chemotherapy.

It is claimed to be the first approved medicine in the US for NSCLC patients who have tested positive for the EGFR T790M mutation.

The company secured fast track, breakthrough therapy and priority review designation for Tagrisso from the FDA. Based on tumour response rate and duration of response, it also received accelerated approval for this indication.

In addition, Tagrisso is being assessed in the adjuvant and metastatic first-line settings, including in patients with and without CNS metastases, leptomeningeal metastases and in combination with other treatments.

AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “By following the science, we aim to turn lung cancer into a chronic, manageable disease for patients and this milestone brings us one step closer to that ambition.

“The FDA’s full approval reinforces the potential of Tagrisso to become the standard of care for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has progressed on or after first-generation EGFR-TKI therapy.”


Image: AstraZeneca’s Tagrisso 80mg once-daily tablet has secured approval from the FDA. Photo: courtesy of AstraZeneca.