Japan’s Pharmaceuticals and Medical Device Agency (PMDA) has approved AstraZeneca’s Tagrisso (osimertinib), combined with pemetrexed and platinum-based chemotherapy, as a first-line treatment for adults with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with exon 19 deletions or exon 21 (L858R) mutations.
This approval is based on the findings from the Phase III FLAURA2 trial, which were published in The New England Journal of Medicine.
Although the overall survival (OS) data is still maturing (41% maturity at the second interim analysis), an encouraging trend towards an OS benefit was noted for the combination therapy compared to monotherapy.
Lung cancer remains the leading cause of cancer-related deaths worldwide and in Japan. It is the second most common cancer in Japan, with over 135,000 new cases diagnosed annually. Among NSCLC patients in Japan, about 36% have tumors with an EGFR mutation, and most are diagnosed at an advanced stage.
The safety profile of Tagrisso combined with chemotherapy was consistent with the established profiles of the individual drugs. Adverse event (AE) rates were higher in the combination therapy group due to well-known chemotherapy-related AEs. The discontinuation rates due to AEs were 11% for the combination therapy and 6% for monotherapy.
Tagrisso is approved as monotherapy in more than 100 countries, including the US, EU, China, and Japan. Approved uses include first-line treatment for patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. Additionally, Tagrisso combined with chemotherapy is approved in the US and several other countries for first-line treatment of locally advanced or metastatic EGFRm NSCLC.
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