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1. Blu-667
2. Cyclohexanecarboxamide, N-((1s)-1-(6-(4-fluoro-1h-pyrazol-1-yl)-3-pyridinyl)ethyl)-1-methoxy-4-(4-methyl-6-((5-methyl-1h-pyrazol-3-yl)amino)-2-pyrimidinyl)-, Trans-
3. Gavreto
4. Trans-n-((1s)-1-(6-(4-fluoro-1h-pyrazol-1-yl)-3-pyridinyl)ethyl)-1-methoxy-4-(4-methyl-6-((5-methyl-1h-pyrazol-3-yl)amino)-2-pyrimidinyl)cyclohexanecarboxamide
1. Blu-667
2. 2097132-94-8
3. Pralsetinib Free Base
4. Gavreto
5. Cis-pralsetinib
6. Blu667
7. Trans-pralsetinib
8. Pralsetinib [inn]
9. Pralsetinib [usan]
10. Blu123244
11. 1wpe73o1wv
12. 2097132-93-7
13. X581238
14. 2097132-94-8 (free Base)
15. Blu-123244
16. N-[(1s)-1-[6-(4-fluoropyrazol-1-yl)pyridin-3-yl]ethyl]-1-methoxy-4-[4-methyl-6-[(5-methyl-1h-pyrazol-3-yl)amino]pyrimidin-2-yl]cyclohexane-1-carboxamide
17. X-581238
18. (cis)-n-((s)-1-(6-(4-fluoro-1h-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-methyl-6-(5-methyl-1h-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide
19. Cis-n-{(1s)-1-[6-(4-fluoro-1h-pyrazol-1-yl)pyridin-3-yl]ethyl}-1-methoxy-4-{4-methyl-6-[(5-methyl-1h-pyrazol-3-yl)amino]pyrimidin-2-yl}cyclohexane-1-carboxamide
20. Cyclohexanecarboxamide, N-((1s)-1-(6-(4-fluoro-1h-pyrazol-1-yl)-3-pyridinyl)ethyl)-1-methoxy-4-(4-methyl-6-((5-methyl-1h-pyrazol-3-yl)amino)-2-pyrimidinyl)-, Cis-
21. Cyclohexanecarboxamide, N-[(1s)-1-[6-(4-fluoro-1h-pyrazol-1-yl)-3-pyridinyl]ethyl]-1-methoxy-4-[4-methyl-6-[(5-methyl-1h-pyrazol-3-yl)amino]-2-pyrimidinyl]-, Cis-
22. Q4j
23. Blu667blu667
24. Cis-blu-667
25. Pralsetinib (usan/inn)
26. Blu-667 (pralsetinib)
27. Unii-1wpe73o1wv
28. Pralsetinib [who-dd]
29. Chembl4582651
30. Schembl18789228
31. Schembl18789229
32. Schembl18806610
33. Gtpl10033
34. Bdbm435009
35. Bdbm435010
36. Dtxsid901336540
37. Amy16875
38. Ex-a1944
39. Ex-a3347
40. Nsc811429
41. S8716
42. Us10584114, Compound 129
43. Us10584114, Compound 130
44. Who 11004
45. Akos037648884
46. Hy-112301a
47. Nsc-811429
48. Ac-35657
49. Bs-15942
50. Hy-112301
51. Cs-0043448
52. Cs-0044766
53. D11712
54. Blu-667; Trans-n-{(1s)-1-[6-(4-fluoro-1h-pyrazol-1-yl)pyridin-3-yl]ethyl}-1-methoxy-4-{4-methyl-6-[(5-methyl-1h-pyrazol-3-yl)amino]pyrimidin-2-yl}cyclohexane-1-carboxamide
55. Trans-n-{(1s)-1-[6-(4-fluoro-1h-pyrazol-1-yl)pyridin-3-yl]ethyl}-1-methoxy-4-{4-methyl-6-[(5-methyl-1h-pyrazol-3-yl)amino]pyrimidin-2-yl}cyclohexane-1-carboxamide
| Molecular Weight | 533.6 g/mol |
|---|---|
| Molecular Formula | C27H32FN9O2 |
| XLogP3 | 3.1 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 8 |
| Exact Mass | 533.26629946 g/mol |
| Monoisotopic Mass | 533.26629946 g/mol |
| Topological Polar Surface Area | 136 Ų |
| Heavy Atom Count | 39 |
| Formal Charge | 0 |
| Complexity | 816 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Treatment of lung cancer (small cell and non-small cell lung cancer )
Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
Treatment of thyroid cancer
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
L01XE
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01E - Protein kinase inhibitors
L01EX - Other protein kinase inhibitors
L01EX23 - Pralsetinib
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GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-26
Pay. Date : 2024-06-17
DMF Number : 39814
Submission : 2024-04-15
Status : Active
Type : II
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GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-14
Pay. Date : 2024-05-20
DMF Number : 39659
Submission : 2024-05-24
Status : Active
Type : II
NDC Package Code : 73005-0010
Start Marketing Date : 2024-02-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Details:
The partnership aims to assist in the commercialization of Rigel Pharmaceuticals' approved product, Gavreto (pralsetinib), which is indicated for RET fusion-positive non-small cell lung cancer.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Rigel Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 27, 2024
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Rigel Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Partnership
Optime Care Announces Enhanced Partnership with Rigel for GAVRETO® Patients
Details : The partnership aims to assist in the commercialization of Rigel Pharmaceuticals' approved product, Gavreto (pralsetinib), which is indicated for RET fusion-positive non-small cell lung cancer.
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 27, 2024
Details:
Through the acquisition, Rigel will able to commercialize the Gavreto (pralsetinib), which is an FDA-approved targeted therapy for RET fusion-positive metastatic non-small cell lung cancer.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Rigel Pharmaceuticals
Deal Size: $117.5 million Upfront Cash: Undisclosed
Deal Type: Acquisition February 22, 2024
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Rigel Pharmaceuticals
Deal Size : $117.5 million
Deal Type : Acquisition
Rigel Pharmaceuticals Acquires U.S. Rights to GAVRETO®
Details : Through the acquisition, Rigel will able to commercialize the Gavreto (pralsetinib), which is an FDA-approved targeted therapy for RET fusion-positive metastatic non-small cell lung cancer.
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 22, 2024
Details:
Under the terms of the agreement, Blueprint Medicines will regain global commercialization and development rights to Gavreto (pralsetinib), a once-daily oral targeted therapy, excluding Greater China.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: F. Hoffmann-La Roche
Deal Size: $1,702.0 million Upfront Cash: $775.0 million
Deal Type: Termination February 23, 2023
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : F. Hoffmann-La Roche
Deal Size : $1,702.0 million
Deal Type : Termination
Blueprint Medicines to Regain Global Rights to GAVRETO® (pralsetinib) from Roche
Details : Under the terms of the agreement, Blueprint Medicines will regain global commercialization and development rights to Gavreto (pralsetinib), a once-daily oral targeted therapy, excluding Greater China.
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : $775.0 million
February 23, 2023
Details:
Gavreto (pralsetinib) is a kinase inhibitor of wild-type RET and oncogenic RET fusions (CCDC6-RET) and mutations. It is approved for adult patients with locally advanced or metastatic RET fusion-positive NSCLC or thyroid cancer and advanced or metastatic RET-mutant MTC.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2023
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
CStone Announces the NDA Approval of GAVRETO® (pralsetinib) for the Treatment of Advanced RET Fus...
Details : Gavreto (pralsetinib) is a kinase inhibitor of wild-type RET and oncogenic RET fusions (CCDC6-RET) and mutations. It is approved for adult patients with locally advanced or metastatic RET fusion-positive NSCLC or thyroid cancer and advanced or metastatic...
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 17, 2023
Details:
GAVRETO is an important precision therapy that has been incredibly meaningful for patients with metastatic, RET fusion-positive non-small cell lung cancer who may have otherwise had limited options.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Royalty Pharma
Deal Size: $340.0 million Upfront Cash: $175.0 million
Deal Type: Collaboration June 30, 2022
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Royalty Pharma
Deal Size : $340.0 million
Deal Type : Collaboration
Details : GAVRETO is an important precision therapy that has been incredibly meaningful for patients with metastatic, RET fusion-positive non-small cell lung cancer who may have otherwise had limited options.
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : $175.0 million
June 30, 2022
Details:
Preclinical data have shown that Gavreto inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2021
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
European Commission Approves Roche’s Gavreto (Pralsetinib) For the Treatment of Adults With RET ...
Details : Preclinical data have shown that Gavreto inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment.
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 19, 2021
Details:
Gavreto® (pralsetinib) is approved once-daily, oral targeted treatment designed to selectively target rearranged during transfection (RET) alterations. Gavreto showed robust and durable clinical responses in people with NSCLC with RET fusions.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Blueprint Medicines
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2021
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Blueprint Medicines
Deal Size : Not Applicable
Deal Type : Not Applicable
Roche Receives Positive CHMP Opinion For Gavreto® (pralsetinib) For the Treatment of Adults With ...
Details : Gavreto® (pralsetinib) is approved once-daily, oral targeted treatment designed to selectively target rearranged during transfection (RET) alterations. Gavreto showed robust and durable clinical responses in people with NSCLC with RET fusions.
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 17, 2021
Details:
Pralsetinib showed robust and durable anti-tumor activity and a well-tolerated safety profile in patients that enrolled at China sites who had advanced RET fusion-positive non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: BLU-667
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Blueprint Medicines
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2021
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Blueprint Medicines
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Pralsetinib showed robust and durable anti-tumor activity and a well-tolerated safety profile in patients that enrolled at China sites who had advanced RET fusion-positive non-small cell lung cancer (NSCLC) previously treated with platinum-based chemothe...
Brand Name : BLU-667
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 28, 2021
Details:
Developed by Blueprint Medicines, GAVRETO is a new therapy indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer as detected by an FDA approved test. This agreement will continue Catalent’s involvement in the GAVRETO program.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Blueprint Medicines
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 23, 2020
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Blueprint Medicines
Deal Size : Undisclosed
Deal Type : Agreement
Details : Developed by Blueprint Medicines, GAVRETO is a new therapy indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer as detected by an FDA approved test. This agreement will continue Catalent’s involvement in ...
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 23, 2020
Details:
GAVRETO demonstrated consistent clinical activity in patients across lines of therapy and regardless of RET mutation genotypes, including a high response rate in patients with gatekeeper mutations resistant to multi-kinase inhibitors.
Lead Product(s): Pralsetinib
Therapeutic Area: Oncology Brand Name: Gavreto
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Genentech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2020
Lead Product(s) : Pralsetinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Genentech
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : GAVRETO demonstrated consistent clinical activity in patients across lines of therapy and regardless of RET mutation genotypes, including a high response rate in patients with gatekeeper mutations resistant to multi-kinase inhibitors.
Brand Name : Gavreto
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 20, 2020
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