Sunitinib Malate
Sunitinib malate was first approved by the U.S. Food and Drug Administration (FDA) on Jan 26, 2006, then approved by European Medicine Agency (EMA) on July 19, 2006, and approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on Apr 16, 2008. It was developed and marketed as Sutent® by Pfizer.
Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. It is indicated for the treatment of gastrointestinal stromal tumor (GIST), advanced renal cell carcinoma (RCC), and pancreatic neuroendocrine tumors (pNET).
Sutent® is available as capsule for oral use, containing 12.5, 25, 37.5 or 50 mg of free Sunitinib. The recommended dose is 50 mg once daily with or without food for GIST and RCC in 4 weeks on treatment, followed by 2 weeks off. Another dose is 37.5 mg once daily with or without food for pNET, continuously without a scheduled off-treatment period.
Update Date：2016-03-14
- Drug Name：
- Sunitinib Malate
- Research Code：
- PNU-290940; SU-11248
- Trade Name：
- Sutent®
- MOA：
- Tyrosine kinase inhibitor
- Indication：
- Renal cell carcinoma; Gastrointestinal stromal tumors (GISTs); Advanced renal cell carcinoma (RCC); Pancreatic neuroendocrine tumors (pNET)
- Status：
- Approved
- Company：
- Pfizer (Originator) , Pfizer
- Sales：
-
$1,120 Million (Y2015);
$1,174 Million (Y2014);
$1,204 Million (Y2013);
$1,236 Million (Y2012);
$1,187 Million (Y2011); - ATC Code：
- L01XE04
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2006-01-26 | Marketing approval | Sutent | Gastrointestinal stromal tumors (GISTs),Advanced renal cell carcinoma (RCC) | Capsule | Eq. 12.5 mg/25 mg/37.5 mg/50 mg Sunitinib | Pfizer | Priority |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2006-07-19 | Marketing approval | Sutent | Gastrointestinal stromal tumors (GISTs),Renal cell carcinoma ,Pancreatic neuroendocrine tumors (pNET) | Capsule | 12.5 mg/25 mg/37.5 mg/50 mg | Pfizer |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2012-08-10 | New indication | Sutent | Pancreatic neuroendocrine tumors (pNET) | Capsule | 12.5 mg | Pfizer | |
| 2008-04-16 | Marketing approval | Sutent | Gastrointestinal stromal tumors (GISTs),Renal cell carcinoma | Capsule | 12.5 mg | Pfizer |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2013-03-29 | Marketing approval | 索坦/Sutent | Gastrointestinal stromal tumors (GISTs),Renal cell carcinoma | Capsule | 12.5 mg/25 mg/37.5 mg/50 mg | Pfizer |
Update Date：2015-08-27
|
Molecular Weight | 532.6 | ||||||||||||
| Formula | C22H27FN4O2 • C4H6O5 | |||||||||||||
| CAS No. |
557795-19-4 (Sunitinib ); 341031-54-7 (Sunitinib Malate); |
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| Chemical Name | N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide mono[(2S)-2-hydroxysuccinate] | |||||||||||||
| Sunitinib （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Update Date：2016-06-01
