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AboutPricing
Drug ReportsEntrectinib
Rozlytrek(entrectinib)
Rozlytrek (entrectinib) is a small molecule pharmaceutical. Entrectinib was first approved as Rozlytrek on 2019-08-15. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat neoplasms and non-small-cell lung carcinoma.
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Drugs Approved for Childhood Cancers
FDA Novel Drug Approvals 2019
Events Timeline
Commercial
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Drug
Target
Variants
Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Rozlytrek
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Entrectinib
Tradename
Company
Number
Date
Products
ROZLYTREKGenentechN-212725 RX2019-08-15
2 products, RLD, RS
ROZLYTREKGenentechN-218550 RX2023-10-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
rozlytrekNew Drug Application2024-11-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
ENTRECTINIB, ROZLYTREK, GENENTECH INC
2030-10-20ODE-448
2026-10-20NP, NPP
2026-08-15ODE-265, ODE-313
2024-08-15NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Entrectinib, Rozlytrek, Genentech Inc
103986932038-07-18DP
112535152038-07-18DP
107380372037-05-18DS, DPU-2946
110914692037-05-18U-2617, U-2618
105616512035-02-19U-2745
102319652035-02-17U-2617, U-2618
90855652033-05-22DS, DP
96493062033-05-22U-2617, U-2618
82990572029-03-01DS, DP
86738932028-07-08U-2617, U-2618
90293562028-07-08DS, DP
90855582028-07-08DP
92550872028-07-08U-2617, U-2618
96160592028-07-08U-2618
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX14: Entrectinib
HCPCS
No data
Clinical
Clinical Trials
45 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80383—213
Non-small-cell lung carcinomaD002289———23——4
Brain neoplasmsD001932EFO_0003833C71141——4
MelanomaD008545———31——3
GliomaD005910EFO_0000520—131——3
Neoplasms by siteD009371———32——3
Hematologic neoplasmsD019337———22——2
Lymphoproliferative disordersD008232Orphanet_2442D47.9—22——2
Neoplasms by histologic typeD009370———22——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——13——14
Neoplasm metastasisD009362EFO_0009708—21——24
Salivary gland neoplasmsD012468EFO_0003826D1113———3
Papillary thyroid cancerD000077273——13———3
Colorectal neoplasmsD015179———2———2
Breast neoplasmsD001943EFO_0003869C50—2———2
Ovarian neoplasmsD010051EFO_0003893C56—2———2
Pancreatic neoplasmsD010190EFO_0003860C25—2———2
Head and neck neoplasmsD006258———2———2
CholangiocarcinomaD018281—C22.1—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver failureD017093—K72.91————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEntrectinib
INNentrectinib
Description
Entrectinib is a member of the class of indazoles that is 1H-indazole substituted by [4-(4-methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzoyl]amino and 3,5-difluorobenzyl groups at positions 3 and 5, respectively. It is a potent inhibitor of TRKA, TRKB, TRKC, ROS1, and ALK (IC50 values of 0.1 to 1.7 nM), and used for the treatment of NTRK, ROS1 and ALK gene fusion-positive solid tumours. It has a role as an antineoplastic agent, an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor, an antibacterial agent and an apoptosis inducer. It is a difluorobenzene, a member of indazoles, a member of benzamides, a N-methylpiperazine, a member of oxanes, a secondary amino compound and a secondary carboxamide.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tropomyosin receptor kinase (TRK) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1CCN(c2ccc(C(=O)Nc3n[nH]c4ccc(Cc5cc(F)cc(F)c5)cc34)c(NC3CCOCC3)c2)CC1
Identifiers
PDB—
CAS-ID1108743-60-7
RxCUI—
ChEMBL IDCHEMBL1983268
ChEBI ID—
PubChem CID25141092
DrugBankDB11986
UNII IDL5ORF0AN1I (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Rozlytrek – Roche
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,488 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,503 adverse events reported
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