AstraZeneca’s Tagrisso has received approval as a monotherapy in more than 100 countries across the globe. Credit: JHVEPhoto / Shutterstock.

AstraZeneca has announced approval from the Japanese Pharmaceuticals and Medical Device Agency for Tagrisso (osimertinib) plus chemotherapy as a first-line treatment of adults with non-small cell lung cancer (NSCLC).

The treatment is indicated for usage along with pemetrexed and platinum-based chemotherapy in locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) NSCLC patients with tumours exhibiting exon 19 deletions or exon 21 (L858R) mutations.

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The latest development was based on the findings from the open-label, randomised, multicentre, global FLAURA2 Phase III trial.

It enrolled 557 subjects at 150 centres in more than 20 countries and regions, including the US, South America, Europe and Asia.

Progression-free survival (PFS) is the trial’s primary endpoint. The study is underway and will progress to evaluate the secondary endpoint of overall survival (OS).

According to the findings, Tagrisso plus chemotherapy demonstrated to lower disease progression or mortality risk by 38% versus Tagrisso monotherapy.

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Median PFS was 25.5 months in Tagrisso plus chemotherapy, an 8.8-month improvement compared to Tagrisso alone.

A trend towards an OS benefit was seen in subjects treated with Tagrisso plus chemotherapy compared to Tagrisso alone.

Tagrisso plus chemotherapy showed a safety profile in line with the established profiles of the individual therapies.

In the Tagrisso plus chemotherapy group, the rate of adverse events was higher and related to chemotherapy.

Tagrisso is currently approved as a monotherapy in more than 100 countries across the globe.

AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “The approval in Japan solidifies Tagrisso as the backbone therapy for patients with EGFR-mutated lung cancer either in combination with chemotherapy or as monotherapy, now providing two effective first-line treatment options.

“The opportunity to combine Tagrisso with chemotherapy is especially important for those patients with a poorer prognosis, such as those whose disease has spread to the brain or those with L858R mutations.”

The latest development comes after the company obtained approval for Truqap (capivasertib) plus Faslodex (fulvestrant) in the European Union (EU) to treat certain advanced breast cancers.