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Larotrectinib Inches Closer to FDA Approval for TRK+ Cancers

Angelica Welch
Published: Monday, May 21, 2018

Anna F. Farago, MD, PhD

Anna F. Farago, MD, PhD
Loxo Oncology completed a rolling new drug application (NDA) to the FDA in March 2018 for larotrectinib (LOXO-101), a pan-TRK inhibitor codeveloped by Bayer. If approved, larotrectinib would be available as a treatment for both adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

in patients with locally advanced solid tumors.

OncLive: Can you provide some background on larotrectinib?

Farago: There have been 3 trials with this drug. There was a phase I study with adult patients, a phase I/II trial for pediatric patients, and a phase II study for adolescents and adults. Those data were put together for a presentation at the 2017 ASCO Annual Meeting, and then in a recent publication in the New England Journal of Medicine. We participated in the phase I adult study and in the phase II adolescent and adult study. 
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