AstraZeneca announced that its cancer drug Tagrisso, in combination with pemetrexed and platinum-based chemotherapy, has received regulatory approvals in both Japan and China.

Japan’s Pharmaceuticals and Medical Device Agency (PMDA) and China’s National Medical Products Administration (NMPA), both approved the combination in the same indication.

Tagrisso plus chemotherapy is indicated for the first-line treatment of adults with metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with exon 19 deletions or exon 21 mutations.  

The cancer drug and chemotherapy combination was approved in the US and other countries for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC

Tagrisso alone, as monotherapy, was approved in over 100 countries, including the US, EU, China, and Japan, to treat EGFRm NSCLC and EGFR T790M mutation-positive NSCLC.

AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “Today’s 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.”

Both the approvals are based on results from the Phase 3 FLAURA2 study of Tagrisso plus chemotherapy as the first-line treatment of metastatic EGFRm NSCLC.

The Phase 3 study enrolled 557 patients at more than 150 centres across 20 countries, including in the US, Europe, South America and Asia.

In the study, patients were treated with once-daily Tagrisso 80mg, pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5) every three weeks, and Tagrisso plus pemetrexed maintenance every three weeks.

The treatment reduced the risk of disease progression or death by 38%, as assessed by an investigator, compared to Tagrisso monotherapy, the 1st-line global standard of care.

Tagrisso plus chemotherapy showed a median progression-free survival (PFS) of 25.5 months, compared to 16.7 months for Tagrisso monotherapy.

The overall survival (OS) remained immature at the second interim analysis, a positive trend towards OS benefit was observed with Tagrisso plus chemotherapy than Tagrisso alone.

Tagrisso plus chemotherapy showed a safety profile that was consistent with the established profiles of the individual medicines, said the British drugmaker.