Larotrectinib / LOXO-101

Target: Trk family | Disease State: Cancer

Introduction / Brief Description

Larotrectinib is an oral and selective inhibitor of tropomyosin receptor kinases (Trk), a family of signaling proteins that are thought to play an important role in cellular communication and tumor growth. Growing research suggests that the NTRK genes, which encode for Trk, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. Larotrectinib targets Trk, turning off the signaling pathway that allows Trk fusion cancers to grow.

In December 2017, Loxo Oncology initiated submission of a rolling New Drug Application (NDA) for larotrectinib to the U.S. FDA, which was completed in March 2018. In May 2018, the FDA accepted the company’s NDA and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).

In July 2013, Array initiated a multi-year license and collaboration agreement with Loxo Oncology for certain Array-invented compounds, including larotrectinib; LOXO-292, a Ret inhibitor; and LOXO-195, a Trk inhibitor.

Loxo will fund Array’s research and will be responsible for target selection and conducting clinical trials. Array has earned $7 million in milestone payment for the advancement of the programs. Array is eligible to receive up to $429 million in additional milestone payments and to receive royalties on sales of any resulting drugs. 

Clinical Trials

To learn more about larotrectinib clinical trials, click here.

These compounds and their uses are investigational and have not been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview of our clinical trials.