AstraZeneca has announced that the EU’s European Commission (EC) has approved Tagrisso (osimertinib), with the addition of pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 mutations.

This approval follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the phase 3 FLAURA2 trial, which were published in The New England Journal of Medicine.

In this trial, Tagrisso, combined with chemotherapy, reduced the risk of disease progression or death by 38% by investigator assessment compared to the drug as a monotherapy, which is the current standard of care.

Median progression-free survival (PFS) was 25.5 months for patients treated with the drug combination, compared to 16.7 months for the group on the monotherapy.

Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, commented: “This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy. This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations.”

David Planchard MD PhD, thoracic oncologist at Gustave Roussy Institute of Oncology, France, and principal investigator for the trial, added: “Today’s news marks a significant advance for patients with EGFR-mutated lung cancer in Europe, providing a new first-line treatment option with osimertinib now in combination with chemotherapy. The FLAURA2 results build on the established efficacy of osimertinib monotherapy, showing a meaningful nine-month improvement in PFS and offering physicians the option to tailor treatment to a patient’s specific needs.”