Entrectinib: First Global Approval.
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Al-Salama ZT, Keam SJ
Entrectinib: First Global Approval.
Drugs. 2019 Aug 1. pii: 10.1007/s40265-019-01177-y. doi: 10.1007/s40265-019-01177-y.
- PubMed ID
- 31372957 [ View in PubMed]
- Abstract
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.
DrugBank Data that Cites this Article
- Drugs
- Drug Enzymes
Drug Enzyme Kind Organism Pharmacological Action Actions Entrectinib Cytochrome P450 3A4 Protein Humans UnknownSubstrateDetails - Drug Interactions
Drugs Interaction Integrate drug-drug
interactions in your softwareEntrectinibPhenytoin The metabolism of Entrectinib can be increased when combined with Phenytoin. EntrectinibPentobarbital The metabolism of Entrectinib can be increased when combined with Pentobarbital. EntrectinibCarbamazepine The metabolism of Entrectinib can be increased when combined with Carbamazepine. EntrectinibMitotane The metabolism of Entrectinib can be increased when combined with Mitotane. EntrectinibPrimidone The metabolism of Entrectinib can be increased when combined with Primidone.