FDA has approved osimertinib, developed by AstraZeneca, for the treatment of adult patients with locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) with EGFR mutations.
The approval was based on efficacy data from the LAURA phase 3 trial, which demonstrated promising results in NSCLC patients who had not progressed after platinum-based chemoradiation.
The FDA highlighted the importance of Project Orbis in facilitating the collaborative review of osimertinib for patients with NSCLC among international regulatory agencies.
Through this initiative, the FDA worked closely with counterparts from Australia, Canada, and Switzerland to streamline the approval process for this promising oncology treatment.
The agency underscored the potential impact of osimertinib in improving outcomes for patients with NSCLC while noting the ongoing reviews by other regulatory bodies.
Source: FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-locally-advanced-unresectable-stage-iii-non-small-cell-lung-cancer
