AstraZeneca has filed and received Priority Review status in the United States for TAGRISSO® (osimertinib) for treating adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations following chemoradiotherapy (CRT). The FDA has also granted Breakthrough Therapy Designation for TAGRISSO in this setting.

The submitted data includes results from the LAURA Phase III trial, which showed that TAGRISSO significantly improved progression-free survival (PFS) compared to placebo. Median PFS was 39.1 months for patients treated with TAGRISSO versus 5.6 months for placebo. This benefit was consistent across various subgroups, including sex, race, and type of EGFR mutation.

Priority Review and Breakthrough Therapy Designation expedite the development and review process for new medicines that address unmet medical needs and demonstrate substantial improvements over existing therapies. Approximately 15% of US NSCLC patients have EGFR mutations, and a significant number are unresectable.

TAGRISSO is currently an established therapy in EGFR-mutated lung cancer. The extended PFS observed in the LAURA trial highlights the importance of EGFR mutation testing at diagnosis. The sNDA approval, anticipated in Q4 2024, would provide a targeted treatment option for patients with Stage III EGFRm NSCLC after CRT.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.