Treats progressive, metastatic medullary thyroid cancer (MTC). NDA 203756, held by Exelixis. Cabozantinib S-Malate.
As of Nov 13, 2026, NDA 203756 (Cometriq), held by Exelixis, was first approved by FDA on Nov 29, 2012, with 8 approved supplements and 0 published complete response letters.
COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
| May 20, 2016 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 29, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| CometriqEQ 20MG BASE · capsule;oral | Cabozantinib S-Malate | RxReference drug |
| CometriqEQ 80MG BASE · capsule;oral | Cabozantinib S-Malate | RxReference drug |
| Oct 9, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Aug 23, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Oct 22, 2020 | Supplement 9Labeling · Standard review | Approved | |
| Jan 31, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Jan 12, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Oct 5, 2017 | Supplement 4Labeling · Standard review | Approved | |
| May 20, 2016 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2014 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Nov 29, 2012 | Original applicationNew molecular entity · 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
