AstraZeneca’s TAGRISSO (osimertinib) has received US approval for treating adults with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC). The approval stems from the LAURA Phase III trial, revealing that TAGRISSO significantly extended progression-free survival (PFS) by 39.1 months compared to 5.6 months with a placebo.
The trial demonstrated an 84% reduction in disease progression or death risk with TAGRISSO. The median PFS was 39.1 months, highlighting the drug’s potential to delay disease progression for over three years. Overall survival (OS) results are still maturing, but the trial continues to assess OS as a secondary endpoint.
The approval is a major advancement for patients with Stage III, EGFR-mutated lung cancer who previously lacked targeted treatment options. Approximately 15% of NSCLC patients in the US have EGFR mutations, and nearly one in five cases of NSCLC have unresectable tumors.
The safety profile of TAGRISSO in the LAURA trial aligns with its established safety data, with no new concerns identified. TAGRISSO is already approved for first-line metastatic and early-stage EGFR-mutated NSCLC. Regulatory authorities worldwide are reviewing TAGRISSO for this indication in other countries.
The approval underscores the importance of early diagnosis and testing for lung cancer to enable timely access to targeted therapies like TAGRISSO, which can significantly improve patient outcomes.
Jon Napitupulu 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.
