AstraZeneca PLC (AZN, AZN.L), a prominent British pharmaceutical company, announced on Thursday the approval of its drug, Tagrisso (osimertinib), by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor (EGFR)-mutated lung cancer.
This decision emerged from a Priority Review by the FDA, driven by results from the LAURA Phase III trial, which demonstrated that Tagrisso extended median progression-free survival (PFS) by over three years.
Although the overall survival (OS) results are still maturing, the trial will continue to evaluate OS as a secondary endpoint.
Tagrisso is designed for patients with exon 19 deletions or exon 21 (L858R) mutations, as identified by an FDA-approved test.
The FDA's approval specifically targets adults with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) whose disease has not advanced during or after concurrent or sequential platinum-based chemoradiation therapy.
In the LAURA trial, Tagrisso decreased the risk of disease progression or death by 84% compared to placebo, as assessed by blinded independent central review. The median PFS for Tagrisso-treated patients was 39.1 months, compared to just 5.6 months for those on placebo.
AstraZeneca highlighted that Tagrisso is approved for first-line metastatic setting in patients with EGFR mutations, both as a monotherapy and in combination with chemotherapy, and as an adjuvant treatment for early-stage disease.
The safety and tolerability observed in the LAURA trial were consistent with Tagrisso's established safety profile, with no new safety concerns identified.
The results of the LAURA Phase III trial were presented during the Plenary Session at the 2024 American Society of Clinical Oncology Annual Meeting and published simultaneously in The New England Journal of Medicine.
Currently, Tagrisso is under review by regulatory authorities in various other countries for this indication. Dave Fredrickson, Executive Vice President of AstraZeneca's Oncology Business Unit, remarked, "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."
