FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Roche’s Cancer NDA Entrectinib Gets Priority Review

Feb. 27, 2019
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The FDA granted priority review to Roche’s entrectinib for treatment of adults and pediatric patients with certain metastatic tumors.

The indication would cover patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of patients with metastatic, ROS1-positive non-small cell lung cancer (NSCLC).

The FDA awarded the priority review based on results from pivotal Phase 2 and Phase I trials as well as data from one additional Phase I trial. A decision on approval is expected by Aug. 18.

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