www.fdanews.com/articles/178291-ariad-pursues-fda-approval-for-lung-cancer-therapy
Ariad Pursues FDA Approval for Lung Cancer Therapy
September 7, 2016
Ariad Pharmaceuticals has finished its rolling NDA for a non-small cell lung cancer therapy that could treat patients resistant to Pfizer’s Xalkori.
The company is requesting accelerated approval and priority review for the application, which, if granted, could shorten the review process to eight months.
In clinical trials, the median progression-free survival for patients was 12.9 months.