Dabrafenib, sold under the brand name Tafinlar, is an anti-cancer medication used to treat cancers associated with a mutated BRAF gene. It is a B-Raf kinase inhibitor that works by blocking the activity of the BRAF V600E mutation, which plays a critical role in uncontrolled cancer cell growth. Dabrafenib is commonly used in the treatment of:
∙ Metastatic melanoma with BRAF V600E mutation
∙ Non-small cell lung cancer (NSCLC) with BRAF mutation
∙ Anaplastic thyroid cancer
It is often used in combination with Trametinib (Mekinist), a MEK inhibitor, to enhance efficacy and prevent drug resistance.
Parent: Dabrafenib/ Dabrafenib Mesylate
Parent: Dabrafenib
Parent: Dabrafenib
Impurities in Dabrafenib can arise due to chemical synthesis, degradation, or improper storage conditions. Regulatory agencies such as the FDA, EMA, and ICH enforce impurity limits to ensure drug safety and efficacy.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
Dabrafenib starts working within days to weeks after starting treatment. Some patients experience tumor shrinkage within 1–2 weeks, but full benefits typically take several months. Response time varies based on:
Common adverse events include:
Serious side effects:
Trametinib (Mekinist) should be stored in the refrigerator (2°C to 8°C / 36°F to 46°F).
The half-life of Dabrafenib is approximately 8 hours. This means:
