NOVARTIS — Tafinlar FDA Review (NDA/BLA 202806, 2019)
Novartis AG · 2019 · FDA Review (Drugs@FDA) · company profile →
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The FDA approved Tafinlar (dabrafenib) as a single agent and in combination with trametinib for unresectable or metastatic melanoma with specific BRAF mutations. This review details the approval, dosage, and warnings. Clinical trials demonstrated Tafinlar's efficacy, particularly in combination with trametinib, showing superior objective response rates, progression-free survival, and overall survival compared to monotherapy. Safety findings highlight adverse events such as hemorrhage, venous thromboembolism, febrile reactions, and cardiac events, with higher incidences often observed with combination therapy. The review also covers pharmacokinetics, nonclinical toxicology, and the regulatory history, including accelerated approval based on significant clinical benefit for this serious disease.
Key findings — cited to the page
| IRRC-assessed ORR | 46 % | Study BRF113220 Part C · p.55 |
| IRRC-assessed ORR | 57 % | Study BRF113220 Part C · p.55 |
| median duration of response by IRRC assessment | 7.6 months | Study BRF113220 Part C · p.55 |
| serious non-infectious, febrile drug reactions (grade 3 pyrexia) | 3 % | BREAK-3 trial (dabrafenib arm) · p.58 |
| Back pain (all grades) | 18 % | Trial 2 · p.71 |
| Back pain (Grades 3 and 4) | 5 % | Trial 2 · p.71 |
| incidence of Arthralgia (all grades) | 27 % | · p.26 |
| incidence of Papilloma (all grades) | 27 % | · p.26 |
| incidence of Cough (all grades) | 12 % | · p.26 |
| incidence of cuSCC (all grades) | 7 % | · p.26 |
| incidence of cuSCC (Grades 3 and 4) | 4 % | · p.26 |
| incidence of Myalgia (all grades) | 11 % | · p.26 |
Source: Novartis 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 →