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
Commercial
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 |
|---|---|---|---|---|
| ROZLYTREK | Genentech | N-212725 RX | 2019-08-15 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rozlytrek | New Drug Application | 2020-06-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ENTRECTINIB, ROZLYTREK, GENENTECH INC | |||
| 2026-08-15 | ODE-265, ODE-313 | ||
| 2024-08-15 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Entrectinib, Rozlytrek, Genentech Inc | |||
| 10398693 | 2038-07-18 | DP | |
| 11253515 | 2038-07-18 | DP | |
| 10738037 | 2037-05-18 | DS, DP | U-2946 |
| 11091469 | 2037-05-18 | U-2617, U-2618 | |
| 10561651 | 2035-02-19 | U-2745 | |
| 10231965 | 2035-02-17 | U-2617, U-2618 | |
| 9085565 | 2033-05-22 | DS, DP | |
| 9649306 | 2033-05-22 | U-2617, U-2618 | |
| 8299057 | 2029-03-01 | DS, DP | |
| 8673893 | 2028-07-08 | U-2617, U-2618 | |
| 9029356 | 2028-07-08 | DS, DP | |
| 9085558 | 2028-07-08 | DP | |
| 9255087 | 2028-07-08 | U-2617, U-2618 | |
| 9616059 | 2028-07-08 | U-2618 | |
HCPCS
No data
Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 4 | — | — | — | 5 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 1 | — | — | — | 2 | |
| Multiple myeloma | D009101 | C90.0 | 1 | 1 | — | — | — | 2 | |
| Invasive hydatidiform mole | D002820 | D39.2 | — | 2 | — | — | — | 2 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 2 | — | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | C26.9 | — | 1 | — | — | — | 1 | |
| Renal cell carcinoma | D002292 | — | 1 | — | — | — | 1 | ||
| Colorectal neoplasms | D015179 | — | 1 | — | — | — | 1 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 2 | — | — | — | — | 2 | |
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ENTRECTINIB |
| INN | entrectinib |
| Description | Entrectinib, sold under the brand name Rozlytrek, is an anti-cancer medication used to treat ROS1-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. It is a selective tyrosine kinase inhibitor (TKI), of the tropomyosin receptor kinases (TRK) A, B and C, C-ros oncogene 1 (ROS1) and anaplastic lymphoma kinase (ALK).
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors: tropomyosin receptor kinase (TRK) inhibitors |
| Image (chem structure or protein) | |
| 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-ID | 1108743-60-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1983268 |
| ChEBI ID | — |
| PubChem CID | 25141092 |
| DrugBank | DB11986 |
| UNII ID | L5ORF0AN1I (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Rozlytrek - Roche
$
€
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,958 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,172 adverse events reported
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