The US Food and Drug Administration (FDA) has approved AstraZeneca‘s Tagrisso (osimertinib) in combination with chemotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor mutations in adults.

This follows a priority review by the regulator and is based on the data from the Phase III FLAURA2 clinical trial.

The international, randomised, open-label, multicentre study involved 557 subjects in 150 centres in more than 20 countries and regions, including Europe, the US, South America and Asia.

It was designed to evaluate Tagrisso administered as 80mg once a day oral tablets, in conjunction with chemotherapy and followed by maintenance therapy.

Results showed a 38% reduction in disease progression risk or mortality with Tagrisso plus chemotherapy versus Tagrisso monotherapy, the current standard of care globally.

Median progression-free survival (PFS) was significantly improved, with subjects in the combination therapy arm showing a median PFS of 25.5 months, an 8.8-month improvement over monotherapy.

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PFS is the trial’s primary endpoint. It will continue to assess the secondary endpoint of overall survival.

The combination regimen’s safety profile was generally manageable, with adverse event rates driven by known chemotherapy-associated effects.

The US regulatory submission was part of Project Orbis, an international effort for the submission and review of cancer therapies.

Tagrisso is already approved as a single agent in more than 100 countries and regions, including the US, EU, Japan and China.

AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the first-line advanced setting.

“This approval re-inforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.”

The latest development comes after AstraZeneca announced plans to invest $300m in a facility in Rockville, Maryland, marking a significant step in launching its cell therapy platforms in the US.