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BRIEF-Loxo Oncology outlines plans for accelerated path to U.S.FDA approval for larotrectinib
December 19, 2016 / 12:39 PM / a year ago

BRIEF-Loxo Oncology outlines plans for accelerated path to U.S.FDA approval for larotrectinib

Dec 19 (Reuters) - Loxo Oncology Inc

* Loxo Oncology outlines plans for accelerated path to U.S.FDA approval for larotrectinib (loxo-101) and provides comprehensive pipeline update

* Loxo Oncology - expects to be in a position to report top-line data for NDA dataset of larotrectinib in second half of 2017

* Loxo Oncology - plans to present clinical data from the scout phase 1/2 trial in pediatric patients in mid-2017

* Loxo Oncology - larotrectinib program currently about 85% enrolled to goal, plans to complete enrollment for primary efficacy analysis in early 2017

* Loxo Oncology - expects to submit nda for larotrectinib in late 2017 or early 2018 and a european marketing authorisation application in 2018 Source text for Eikon: Further company coverage:

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