AstraZeneca Plc, the renowned British pharmaceutical company, revealed on Monday that the European Commission has sanctioned the use of Tagrisso (osimertinib) for adult patients diagnosed with locally advanced, unresectable non-small cell lung cancer (NSCLC) throughout the European Union.
This approval marks Tagrisso as the pioneering EGFR inhibitor and targeted therapy endorsed within the EU for cases involving unresectable NSCLC. Specifically targeted for NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, the treatment is intended for those whose disease has remained stagnant during or after platinum-based chemoradiation therapy (CRT).
This decision by the European Commission was informed by a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) in mid-November. It is underpinned by findings from the LAURA Phase III trial, demonstrating that Tagrisso extended median progression-free survival to over three years. These findings were published in The New England Journal of Medicine.
Within the trial, Tagrisso was shown to decrease the risk of disease progression or mortality by 84% compared to a placebo, as evaluated by an independent central review. Patients receiving Tagrisso experienced a median progression-free survival (PFS) of 39.1 months, contrasting with 5.6 months for those on placebo.
The safety profile and tolerability of Tagrisso in the LAURA trial were consistent with previous findings, with no new safety issues detected. Although overall survival (OS) results are still maturing, the trial continues to explore OS as a secondary outcome measure.
Dave Fredrickson, Executive Vice President of the Oncology Business Unit at AstraZeneca, stated, "Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer. It establishes a new care standard for patients who historically faced early disease progression post-chemoradiation therapy. The compelling results from the LAURA trial highlight Tagrisso's potential to improve patient outcomes and underscore the necessity of prompt EGFR testing, cementing Tagrisso's role as a foundational therapy in EGFR-mutated non-small cell lung cancer."
In addition to the EU, the LAURA trial has facilitated Tagrisso's approval in the US, Switzerland, South Korea, and Australia. Further regulatory evaluations are ongoing in China, Japan, and several other nations.
Tagrisso is currently approved as a monotherapy in over 100 countries, including the US, EU, China, and Japan, for various NSCLC indications. It is also sanctioned for combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC in the US, China, and additional countries.
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