GENENTECH INC — Cotellic FDA Summary Review (NDA/BLA 206192, 2015)
Roche Holding AG · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA approval of cobimetinib (Cotellic) in combination with vemurafenib for BRAF V600 mutation-positive unresectable or metastatic melanoma. Based on Study GO28141, the combination therapy significantly improved progression-free and overall survival compared to vemurafenib monotherapy. The report covers regulatory history, CMC, nonclinical data, and clinical pharmacology, including drug-drug interactions and the need for post-marketing studies on hepatic impairment. Key safety concerns include malignancies, hemorrhage, cardiomyopathy, severe skin reactions, hepatotoxicity, rhabdomyolysis, severe photosensitivity, and serous retinopathy. Post-marketing studies are mandated to further assess hepatic impairment and serous retinopathy risks.
Key findings — cited to the page
| overall incidence of hemorrhage (Grades 1-4) in cobimetinib plus vemurafenib arm | 13 % | · p.25 |
| incidence of Grade 3 to 4 rash in cobimetinib with vemurafenib arm | 14 % | · p.25 |
| Grade 3 or 4 laboratory abnormalities: GGT | 13 % | · p.24 |
| incidence of Grade 3-4 hemorrhages in vemurafenib arm | 0.8 % | · p.25 |
| incidence of Grade 2-3 decreases in LVEF in cobimetinib with vemurafenib arm | 26 % | · p.25 |
| incidence of Grade 2-3 decreases in LVEF in vemurafenib arm | 19 % | · p.25 |
| Grade 3 or 4 laboratory abnormalities: AST | 9 % | · p.24 |
| Grade 3 or 4 laboratory abnormalities: creatine phosphokinase | 13 % | · p.24 |
| Grade 3 or 4 laboratory abnormalities: ALT | 11 % | · p.24 |
| incidence of Grade 3-4 hemorrhages in cobimetinib plus vemurafenib arm | 1.2 % | · p.25 |
| overall incidence of hemorrhage (Grades 1-4) in vemurafenib arm | 7 % | · p.25 |
| incidence of Grade 3 to 4 rash in vemurafenib arm | 13 % | · p.25 |
Source: Roche Holding AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →