USA—AstraZeneca has announced that Tagrisso (osimertinib) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

This approval is specifically for lung cancer patients whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy (CRT).

In a statement, AstraZeneca highlighted that Tagrisso is intended for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test.

The announcement comes just a month after Health Canada granted a Notice of Compliance (NOC) for the drug, in combination with pemetrexed and platinum-based chemotherapy, for patients with locally advanced or metastatic NSCLC harbouring these same mutations.

The FDA approved the product based on the results of the LAURA Phase III trial, which received Priority Review status.

The findings were presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and were simultaneously published in The New England Journal of Medicine.

According to the trial data, Tagrisso reduced the risk of disease progression or death by 84% compared to the placebo, as assessed by a blinded independent central review.

The safety and tolerability profile of Tagrisso in this trial was consistent with previous studies, with no new safety concerns identified.

Lung cancer remains a major health issue in the U.S., with more than 200,000 people diagnosed each year. NSCLC is the most common type, accounting for 80-85% of all cases.

Among NSCLC patients, around 15% have EGFR mutations, and nearly one in five patients present with unresectable tumours, making effective treatment options particularly crucial.

Commenting on the trial results, Dr. Suresh Ramalingam, the principal investigator of the LAURA trial, described the FDA’s approval as a significant milestone for patients with Stage III, EGFR-mutated lung cancer.

He emphasised that osimertinib extended patients’ disease-free survival by over three years, highlighting the importance of early diagnosis and testing.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, echoed these sentiments, noting that Tagrisso’s approval meets an urgent need for targeted therapies in patients with EGFR mutations who previously had no such option.

 He added that the LAURA trial results underscore the drug’s potential as a backbone therapy for this form of lung cancer.

With this latest approval, Tagrisso is now available for patients with EGFR mutations in several treatment settings, including as a first-line monotherapy for metastatic disease, combined with chemotherapy, and as an adjuvant treatment for early-stage lung cancer.

Regulatory reviews for Tagrisso’s expanded use are still ongoing in other countries worldwide.

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