Gavreto(pralsetinib)
Gavreto (pralsetinib) is a small molecule pharmaceutical. Pralsetinib was first approved as Gavreto on 2020-09-04. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against proto-oncogene tyrosine-protein kinase receptor Ret. In addition, it is known to target vascular endothelial growth factor receptor 2.
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FDA Novel Drug Approvals 2020
Commercial
Trade Name
FDA
EMA
Gavreto
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pralsetinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GAVRETO | Genentech | N-213721 RX | 2020-09-04 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gavreto | New Drug Application | 2021-04-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PRALSETINIB, GAVRETO, GENENTECH INC | |||
| 2027-12-01 | ODE-340, ODE-341 | ||
| 2027-09-04 | ODE-318 | ||
| 2025-09-04 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
11 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 |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 1 | 4 | 1 | — | 1 | 6 | |
| Non-small-cell lung carcinoma | D002289 | 1 | 3 | 2 | — | 1 | 6 | ||
| Papillary thyroid cancer | D000077273 | 1 | 1 | 1 | — | 1 | 3 | ||
| Head and neck neoplasms | D006258 | 1 | 1 | 1 | — | — | 2 | ||
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | 1 | — | — | 2 | |
| Respiratory tract diseases | D012140 | 1 | 1 | 1 | — | — | 2 | ||
| Germ cell and embryonal neoplasms | D009373 | 1 | 1 | 1 | — | — | 2 | ||
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 1 | 1 | — | — | 2 |
| Respiratory tract neoplasms | D012142 | EFO_0003853 | D14 | 1 | 1 | 1 | — | — | 2 |
| Bronchogenic carcinoma | D002283 | 1 | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal neoplasms | D005770 | C26.9 | 1 | 2 | — | — | — | 2 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | 1 | 1 | — | — | — | 1 | ||
| Thyroid neoplasms | D013964 | EFO_0003841 | 1 | 1 | — | — | — | 1 | |
| Digestive system neoplasms | D004067 | 1 | 1 | — | — | — | 1 | ||
| Gastrointestinal diseases | D005767 | 1 | 1 | — | — | — | 1 | ||
| Colonic neoplasms | D003110 | C18 | 1 | 1 | — | — | — | 1 | |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 1 | 1 | — | — | — | 1 |
| Neuroendocrine carcinoma | D018278 | 1 | 1 | — | — | — | 1 | ||
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PRALSETINIB |
| INN | pralsetinib |
| Description | Pralsetinib, sold under the brand name Gavreto, is a medication approved RET mutation-positive medullary thyroid cancer (MTC) and RET fusion-positive differentiated thyroid cancer (DTC) refractory to radioactive iodine (RAI) therapy. Pralsetinib is a tyrosine kinase inhibitor. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CO[C@]1(C(=O)N[C@@H](C)c2ccc(-n3cc(F)cn3)nc2)CC[C@H](c2nc(C)cc(Nc3cc(C)[nH]n3)n2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 2097132-94-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4582651 |
| ChEBI ID | — |
| PubChem CID | 129073603 |
| DrugBank | DB15822 |
| UNII ID | 1WPE73O1WV (ChemIDplus, GSRS) |
Target
Agency Approved
RET
RET
Organism
Homo sapiens
Gene name
RET
Gene synonyms
CDHF12, CDHR16, PTC, RET51
NCBI Gene ID
Protein name
proto-oncogene tyrosine-protein kinase receptor Ret
Protein synonyms
Cadherin family member 12, cadherin-related family member 16, Proto-oncogene c-Ret, rearranged during transfection, ret proto-oncogene (multiple endocrine neoplasia and medullary thyroid carcinoma 1, Hirschsprung disease), RET receptor tyrosine kinase
Uniprot ID
Mouse ortholog
Ret (19713)
proto-oncogene tyrosine-protein kinase receptor Ret (P35546)
Alternate
KDR
KDR
Organism
Homo sapiens
Gene name
KDR
Gene synonyms
FLK1, VEGFR2
NCBI Gene ID
Protein name
vascular endothelial growth factor receptor 2
Protein synonyms
CD309, Fetal liver kinase 1, fetal liver kinase-1, FLK-1, KDR, Kinase insert domain receptor, kinase insert domain receptor (a type III receptor tyrosine kinase), Protein-tyrosine kinase receptor flk-1, soluble VEGFR2, tyrosine kinase growth factor receptor
Uniprot ID
Mouse ortholog
Kdr (16542)
vascular endothelial growth factor receptor 2 (Q8VCD0)
Variants
Clinical Variant
No data
Financial
Gavreto - Blueprint Medicines
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£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 482 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,502 adverse events reported
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