AstraZeneca‘s supplemental new drug application for Tagrisso has obtained priority review from the US Food and Drug Administration (FDA) for unresectable Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT).
On receipt of approval, the product will be used to treat patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
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A decision on the approval of the product under the Prescription Drug User Fee Act is expected in the fourth quarter of 2024.
The sNDA submission is supported by results from the double-blind, randomised, placebo-controlled, multi-centre, global LAURA Phase III trial.
Participants received Tagrisso 80mg once daily oral tablets until experiencing disease progression or unacceptable toxicity, or meeting other discontinuation criteria.
Patients in the placebo group were allowed to switch to Tagrisso upon disease progression.
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By GlobalDataThe trial involved 216 patients across 145 centres in more than 15 countries.
Tagrisso lowered disease progression or mortality risk by 84% versus placebo, with a median progression-free survival (PFS) of 39.1 months versus 5.6 months for the placebo group.
The PFS benefit was significant across all prespecified subgroups.
While overall survival data showed a favourable trend, it was not mature at the time of analysis.
Safety results and discontinuation rates due to adverse events were consistent with the known profile of Tagrisso, and no new safety concerns were identified.
Tagrisso previously received breakthrough therapy designation from the FDA in this treatment setting.
AstraZeneca oncology research and development executive vice-president Susan Galbraith 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 on an accelerated path to bring Tagrisso to patients as a potential new standard of care as quickly as possible.
“Tagrisso continues to serve patients as a backbone therapy in EGFR-mutated lung cancer, extending progression-free survival in the LAURA trial by more than three years and reinforcing the importance of testing for EGFR mutations at the time of diagnosis.”
The latest development comes after AstraZeneca concluded the acquisition of clinical-stage biopharmaceutical company Fusion Pharmaceuticals.
