ARTICLE | Clinical News

Larotrectinib regulatory update

December 21, 2016 1:01 AM UTC

In a pipeline update, Loxo said it expects to submit an NDA to FDA for larotrectinib by early 2018, with an EMA submission to follow in 2018. The company said it has reached 85% enrollment in its Phase II NAVIGATE trial, a basket trial enrolling patients with tropomyosin receptor kinase (TRK) fusion cancers across tumor types. In 2H17, the company expects to report top-line NAVIGATE data, which it said will form the basis of the NDA...