AstraZeneca has received the US Food and Drug Administration (FDA) approval for Tagrisso (osimertinib) with chemotherapy for patients with epidermal growth factor receptor-mutated (EGFRm) advanced lung cancer.

Tagrisso is a third-generation, irreversible EGFR-tyrosine kinase inhibitor (EGFR-TKI).

It has been approved in the US with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, as discovered by an FDA-authorised test.

The approval follows a Priority Review by the US FDA and was based on the findings from the FLAURA2 Phase 3 trial.

The randomised, open-label, multi-centre study assessed the cancer drug in 557 patients with locally advanced or metastatic EGFRm NSCLC.

In the trial, the patients were randomised 1:1 to get either osimertinib with platinum-based chemotherapy or osimertinib monotherapy.

The primary endpoint is defined as progression-free survival (PFS). The late-stage study is ongoing and will continue to evaluate the secondary endpoint of overall survival (OS).

According to the results, Tagrisso with chemotherapy reduced the risk of disease progression or death by 38% compared to osimertinib monotherapy.

Patients treated with Tagrisso + chemotherapy had a median progression-free survival (PFS) of 25.5 months, which is an 8.8-month improvement over Tagrisso monotherapy.

Additionally, the PFS data from a blinded independent central review (BICR) showed a 9.5-month improvement over Tagrisso monotherapy, with a median PFS of 29.4 months when combined with chemotherapy.

AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “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 1st-line advanced setting.

“This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy. This news is especially important for those with a poorer prognosis, including patients whose cancer has spread to the brain and those with L858R mutations.”

In June last year, AstraZeneca announced positive results for its cancer drug in the treatment of certain NSCLC patients in the Phase 3 ADAURA trial.