BioCentury
ARTICLE | Company News

Priority Review for Loxo's larotrectinib in tissue-agnostic indication

May 29, 2018 2:43 PM UTC

FDA accepted and granted Priority Review to an NDA for larotrectinib (LOXO-101) from Loxo Oncology Inc. (NASDAQ:LOXO) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion proteins, regardless of tissue of origin. Its PDUFA date is Nov. 26.

Loxo's development program for larotrectinib was designed specifically to enroll a genetically defined patient population. The therapy has breakthrough therapy, rare pediatric disease and Orphan Drug designations from FDA (see BioCentury, June 13, 2016)...