Treats advanced renal cell carcinoma (RCC). NDA 208692, held by Exelixis Inc. Cabozantinib S-Malate.
As of Nov 13, 2026, NDA 208692 (Cabometyx), held by Exelixis Inc, was first approved by FDA on Apr 25, 2016, with 14 approved supplements and 0 published complete response letters.
CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2025 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Mar 26, 2025 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Jul 14, 2022 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Sep 17, 2021 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jan 22, 2021 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Jan 14, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2017 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Apr 25, 2016 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CabometyxEQ 20MG BASE · tablet;oral | Cabozantinib S-Malate | RxReference drug |
| CabometyxEQ 40MG BASE · tablet;oral | Cabozantinib S-Malate | RxReference drug |
| CabometyxEQ 60MG BASE · tablet;oral | Cabozantinib S-Malate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2025 | Supplement 19Labeling · Standard review | Approved | |
| Sep 10, 2025 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Mar 26, 2025 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Sep 20, 2023 | Supplement 16Labeling · Standard review | Approved | |
| Feb 13, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Jul 14, 2022 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Sep 17, 2021 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jan 22, 2021 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Nov 5, 2020 | Supplement 9Manufacturing | Approved | |
| Jul 16, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Jan 31, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Jan 14, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2017 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Nov 16, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Apr 25, 2016 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
