Entrectinib: First Global Approval

doi:10.1007/s40265-019-01177-y

2019-08-01

119

PRE

Zaina T. Al-Salama *

Susan J. Keam

DOI：10.1007/s40265-019-01177-y

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摘要

En 中文

Entrectinib (Rozlytrek (R)) is an oral selective inhibitor of the tyrosine kinases tropomyosin receptor kinases (Trk)A/B/C [encoded by the genes neurotrophic tyrosine receptor kinase (NTRK) 1, 2 and 3, respectively], c-ros oncogene 1 (ROS1) and anaplastic lymphoma kinase (ALK) with central nervous system (CNS) activity developed by Roche for the treatment of various solid tumours harbouring NTRK1/2/3 or ROS1 gene fusions. In June 2019, entrectinib received its first global approval in Japan, for the treatment of adult and paediatric patients with NTRK fusion-positive, advanced or recurrent solid tumours and is under regulatory review for the treatment of adult patients with ROS1-positive non-small cell lung cancer (NSCLC). Entrectinib is also under regulatory review in the USA (PDUFA date 18 August 2019) and EU [Priority Medicines (PRIME) designation] for NTRK-positive solid tumours and ROS1-positive NSCLC. This article summarizes the milestones in the development of entrectinib leading to this first global approval for solid tumours in Japan.

Keyword:

PAN-TRK

ALK INHIBITOR

ANTITUMOR-ACTIVITY

ROS1

EFFICACY

SAFETY

TUMORS

NTRK

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