Tagrisso Receives US Priority Review for Unresectable Stage III EGFR-Mutated Lung Cancer

AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso has been accepted and granted Priority Review in the US for treating adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT). If approved, Tagrisso will be indicated for patients with EGFRm tumors featuring exon 19 deletions or exon 21 (L858R) mutations.

The FDA grants Priority Review to applications for medicines that could significantly improve safety, efficacy, or patient compliance compared to existing treatments. The Prescription Drug User Fee Act date, the FDA action date for their decision, is anticipated in Q4 2024.

Tagrisso also recently received Breakthrough Therapy Designation (BTD) from the FDA, expediting its development and review process. BTD is awarded to potential new treatments for serious conditions that address significant unmet medical needs.

In the US, nearly 200,000 people are diagnosed with lung cancer annually, with 80-85% having NSCLC. Approximately 15% of NSCLC patients in the US have EGFR mutations, and nearly one in five newly diagnosed NSCLC cases are unresectable.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated, “Priority Review of Tagrisso in this early-stage curative setting is important for patients who currently have no targeted treatments available. We look forward to close collaboration with the FDA to bring Tagrisso to patients as a potential new standard of care as quickly as possible.”

The sNDA is based on data from the LAURA Phase III trial, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. The trial showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, with a median progression-free survival (PFS) of 39.1 months versus 5.6 months for placebo. A clinically meaningful PFS benefit was observed across all prespecified subgroups.

Overall survival (OS) data showed a favorable trend for Tagrisso, though the data were not mature at the time of analysis. Safety results were consistent with Tagrisso’s known profile, with no new safety concerns identified.

Tagrisso is approved as monotherapy in over 100 countries, including the US, EU, China, and Japan, for various stages of EGFRm NSCLC. It is also approved in combination with chemotherapy for first-line treatment of locally advanced or metastatic EGFRm NSCLC in several countries.

The ongoing LAURA Phase III trial enrolled 216 patients across more than 145 centers in over 15 countries. Tagrisso is being investigated in various settings, including the NeoADAURA and ADAURA2 Phase III trials for early-stage disease and combination trials addressing resistance mechanisms.

AstraZeneca aims to advance lung cancer treatment through early detection, innovative therapies, and a comprehensive portfolio, including Tagrisso, Imfinzi, Imjudo, Enhertu, Orpathys, and other potential new medicines. The company is a founding member of the Lung Ambition Alliance, a global coalition working to improve lung cancer outcomes.

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