CHMP recommends AstraZeneca’s Tagrisso for approval for lung cancer treatment
Betsy Goodfellow | June 3, 2024 | News story | Medical Communications | CHMP, EMA, Oncology, Tagrisso, lung cancer
AstraZeneca has announced that Tagrisso (osimertinib) alongside pemetrexed and platinum-based chemotherapy, has been recommended for approval in the EU for 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 of exon 21 (L858R) mutations.
This recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) was based on results from the FLAURA2 phase 3 trial, which have also been published in full in The New England Journal of Medicine.
These results demonstrated that Tagrisso, with chemotherapy, reduced the risk of disease progression of death by 38% compared to Tagrisso as a monotherapy, which is the current global standard of care. Median progression-free survival was 25.5 months for those treated with Tagrisso and chemotherapy, 8.8 months longer than Tagrisso alone (16.7 months).
Overall survival (OS) data was immature at this interim analysis, however there was a positive trend towards an OS benefit for Tagrisso with chemotherapy. The trial will continue to assess OS as it progresses.
Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, commented: “Today’s news reinforces the importance of Tagrisso as the backbone therapy in EGFR-mutated lung cancer. If approved in Europe, patients will have the option to be treated with Tagrisso alone, or with chemotherapy, which is especially important when caring for patients whose disease has spread to the brain or those with L858R mutations.”
Betsy Goodfellow
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