FDA Grants Larotrectinib Priority Review for NTRK+ Cancers

May 29, 2018 – The FDA has granted a priority review to a new drug application (NDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an NTRK gene fusion, according to Bayer and Loxo Oncology, the codevelopers of the pan-TRK inhibitor. The NDA is based on findings from patients with TRK-positive tumors enrolled across phase I or II clinical trials. In results published in the New England Journal of Medicine … (leggi tutto)