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Repotrectinib receives orphan drug designation in Korea

By Eo, Yun-Ho | translator Kang, Shin-Kook

24.05.17 05:40:22

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Raises expectations on its use in ROS1-positive NSCLC and NTRK fusion-positive solid tumors

Clinical trial that Professor Byoung-Chul Cho of Yonsei Cancer Hospital participated in was published in NEJM


, The  ROS1-targeted lung cancer drug repotrectinib received an orphan drug designation in Korea.

The Ministry of Food and Drug Safety (MFDS) announced the designation in a recent announcement.

Specifically, the indications repotrectinib received orphan drug designation for are as follows: ¡ã treatment for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) ¡ã treatment for patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.

Repotrectinib was first approved by the US

Eo, Yun-Ho(unkindfish@dailypharm.com)
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