Tagrisso plus chemo approved in Japan as new first-line therapy

US pharma major AstraZeneca (LSE: AZN) today revealed that its Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in Japan for the first-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

The approval by the Japanese Pharmaceuticals and Medical Device Agency (PMDA) was based on the results from the FLAUR2 Phase III trial.

Results showed the Tagrisso combination reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the first-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). Median progression-free survival (PFS) was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).