AstraZeneca wins US approval for Tagrisso lung cancer drug

Tagrisso is indicated to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

In two clinical trials of 411 subjects, 57% and 61% of patients experienced a complete or partial reduction in their tumor size, with the most common side effects being diarrhea, skin and nail conditions.

AstraZeneca CEO Pascal Soriot said: "The FDA approval of Tagrisso marks an important milestone for lung cancer patients who urgently need new treatment options."

Tagrisso is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitising mutations (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance.

In the AURA3 open label, randomised Phase III trial, AstraZeneca is evaluating the efficacy and safety of Tagrisso versus platinum-based doublet chemotherapy in patients with EGFR T790M positive, locally advanced, or metastatic NSCLC who have progressed following prior therapy with an EGFR-TKI.

It is also being evaluated in the adjuvant setting and in the metastatic first-line setting, including in patients with brain metastases, as well as in combination with other compounds.

The FDA has also approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to identify the type of EGFR resistance mutation that Tagrisso is known to target.

Roche Molecular Systems is marketing the cobas EGFR Mutation Test v2, which adds the T790M mutation to the clinically relevant mutations identified by the original cobas EGFR Mutation Test (v1).

Image: AstraZeneca Headquarters, London, UK. Photo: courtesy of AstraZeneca.