AstraZeneca’s Tagrisso approved in Japan for lung cancer treatment
Betsy Goodfellow | June 25, 2024 | News story | Medical Communications | AstraZeneca, Oncology, Tagrisso, chemotherapy, lung cancer
AstraZeneca has announced that Tagrisso (osimertinib) in combination with 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 mutations.
This approval by the Japanese Pharmaceuticals and Medical Device Agency (PMDA) follows results from the FLAURA2 phase 3 trial, which were published in The New England Journal of Medicine.
The results showed that Tagrisso, in combination with chemotherapy, reduced the risk of disease progression or death by 38% compared to Tagrisso as a monotherapy, which is currently the first line standard of care. The median progression-free survival (PFS) was 25.5 months for those treated with Tagrisso and chemotherapy, compared to 16.7 months for Tagrisso as a monotherapy.
Overall survival (OS) data was immature at the second interim analysis, however an encouraging trend towards OS benefit was observed in the trial.
Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, commented: “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.”
Betsy Goodfellow
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