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FDA Prioritizes AstraZeneca's Tagrisso sNDA for Priority Review in Unresectable Stage III NSCLC

NextEdge Admin

10 Jun 2024

3 min 4 sec

The US Food and Drug Administration (FDA) has prioritized the review of AstraZeneca's supplemental new drug application (sNDA) for Tagrisso (osimertinib) as a treatment for unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) post-chemoradiotherapy. This decision comes following compelling data from the Phase III LAURA trial, presented at the American Society of Clinical Oncology's recent annual meeting and published in the New England Journal of Medicine.

In the LAURA trial, Tagrisso demonstrated significant efficacy, reducing the risk of disease progression or death by a remarkable 84% compared to placebo, as assessed by blinded independent central review. While there was an observed trend indicating potential for improved overall survival with Tagrisso compared to placebo, mature data for overall survival were not available at the time of the analysis cutoff.

Susan Galbraith, AstraZeneca's executive VP of oncology R&D, emphasized the critical need for targeted treatments in this early-stage curative setting, where currently there are limited options available to patients. Galbraith expressed anticipation for collaborative efforts with the FDA to expedite Tagrisso's approval process, aiming to establish it as a potential new standard of care for this patient population.

Tagrisso is already approved for various indications, including advanced EGFR-mutated NSCLC, NSCLC with EGFR T790M resistance mutations, and adjuvant treatment of early-stage EGFR-mutated NSCLC. Moreover, in combination with chemotherapy, Tagrisso is an approved frontline therapy for locally advanced or metastatic EGFR-mutated NSCLC.

Galbraith highlighted Tagrisso's role as a foundational therapy in EGFR-mutated lung cancer, extending progression-free survival by over three years in the LAURA trial. She underscored the significance of EGFR mutation testing at diagnosis, reinforcing the importance of personalized treatment approaches in NSCLC management.

The FDA is anticipated to reach a decision on the sNDA for Tagrisso by Q4 2024, potentially offering a promising new treatment avenue for patients with unresectable, stage III EGFR-mutated NSCLC post-chemoradiotherapy.