Cabozantinib S-malate was approved by the U.S. Food and Drug Administration (FDA) on November 29, 2012, then approved by European Medicine Agency (EMA) on March 21, 2014. It was developed and marketed as Cometriq® by Exelixis in the US.
Cabozantinib S-malate is a multiple receptor tyrosine kinases inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
Cometriq® is available as capsule for oral use, containing 20 or 80 mg of free Cabozantinib, and the recommended dose is 140 mg once daily.
Update Date:2016-05-16
Update Date:2016-05-16
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2016-04-25 | New indication | Cabometyx | Advanced renal cell carcinoma (RCC) | Tablet | Eq. 20 mg/40 mg/60 mg Cabozantinib | Exelixis | |
2012-11-29 | Marketing approval | Cometriq | Medullary thyroid cancer (MTC) | Capsule | Eq. 20 mg/80 mg Cabozantinib | Exelixis | Priority; Orphan |
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2014-03-21 | Marketing approval | Cometriq | Medullary thyroid cancer (MTC) | Capsule | 20 mg/80 mg | TMC Pharma | Orphan; Conditional Approval |
Update Date:2015-09-16
Update Date:2015-12-03
Update Date:2016-05-11
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