AstraZeneca: FDA Approves Tagrisso To Treat Unresectable Stage III Lung Cancer

(RTTNews) - British drug major AstraZeneca PLC (AZN, AZN.L) announced Thursday that its Tagrisso (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor or EGFR-mutated lung cancer.

The decision follows a Priority Review by the U.S. Food and Drug Administration that was based on results from the LAURA Phase III trial, which showed Tagrisso extended median progression-free survival by more than three years.

The company further noted that overall survival or OS results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

Tagrisso is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test.

The FDA approval is for treating aduults with unresectable, Stage III EGFR-mutated non-small cell lung cancer or NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy.

In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo as assessed by blinded independent central review. Median progression-free survival or PFS was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.

AstraZeneca noted that Tagrisso is approved for patients with EGFR mutations in the 1st-line metastatic setting as a monotherapy and in combination with chemotherapy, and as an adjuvant treatment for early-stage disease.

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were identified.

The LAURA Phase III trial results were presented during the Plenary Session at the 2024 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine.

Tagrisso is currently under review with regulatory authorities in other countries around the world for this indication. Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said, "The approval of Tagrisso for patients with Stage III, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before. The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung cancer can now benefit."

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