Treats unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. NDA 206192, held by Genentech Inc. Cobimetinib Fumarate.
As of Nov 14, 2026, NDA 206192 (Cotellic), held by Genentech Inc, was first approved by FDA on Nov 10, 2015, with 6 approved supplements and 0 published complete response letters.
COTELLIC is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1, 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2, 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.
| Oct 28, 2022 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jul 28, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jan 26, 2018 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 10, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CotellicEQ 20MG BASE · tablet;oral | Cobimetinib Fumarate | RxReference drug |
| Aug 20, 2026 | Supplement 7Labeling · Standard review | Approved | |
| May 31, 2023 | Supplement 6Labeling · Standard review | Approved | |
| Oct 28, 2022 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jul 28, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jan 26, 2018 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| May 31, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Nov 10, 2015 | 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
