AstraZeneca has gained approval from the European Commission (EC) for its oral therapy, Tagrisso (osimertinib), to treat adults with locally advanced, unresectable non-small cell lung cancer (NSCLC).
This approval in the European Union (EU) is specifically for cases where tumours exhibit epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, and where the disease has not progressed during or after platinum-based chemoradiation therapy (CRT).
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The EC’s decision follows the Committee for Medicinal Products for Human Use’s positive opinion and is underpinned by the outcomes from the multi-centre, randomised Phase III LAURA trial.
In this study, the therapy significantly decreased the disease progression or mortality risk by 84% versus placebo, with a median progression-free survival (PFS) of 39.1 months.
While overall survival (OS) data are still maturing, the trial continues to evaluate OS as a secondary endpoint. Tagrisso’s safety profile in the trial aligned with previous findings, presenting no new safety concerns.
AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy.
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By GlobalData“The powerful results from the LAURA trial show Tagrisso improves outcomes for patients in the unresectable setting, reinforces the importance of timely EGFR testing, and solidifies Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer.”
This latest approval marks the fifth authorisation for the therapy based on the ‘LAURA’ outcomes, following recent approvals in the US, Australia, Switzerland, and South Korea. Regulatory reviews are underway in China, Japan, and other nations.
Globally, the therapy is approved as a single agent in over 100 nations, including the EU, China, and Japan.
In June this year, Japan’s Pharmaceuticals and Medical Device Agency approved Tagrisso in conjunction with chemotherapy for first-line treatment in adult patients with NSCLC.
