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Dabrafenib
Source: Melanoma Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
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Dabrafenib is an orally available, small-molecule, selective BRAF inhibitor that was approved by the FDA in 2013. It is used for the treatment of patients with unresectable or metastatic melanoma and BRAF V600E pathogenic variants as detected by an FDA-approved test. Dabrafenib and other BRAF inhibitors are not recommended for the treatment of BRAF wild-type melanomas, as in vitro experiments suggest there may be a paradoxical stimulation of MAPK signaling resulting in tumor promotion.
Evidence (dabrafenib):
An international multicenter trial (BREAK-3 [NCT01227889]) compared dabrafenib with dacarbazine. A total of 250 patients with unresectable stage III or IV melanoma and BRAF V600E pathogenic variants were randomly assigned in a 3:1 ratio to receive dabrafenib (150 mg by mouth daily) or dacarbazine (1,000 mg/m2 IV every 3 weeks). IL-2 was allowed as a previous treatment for advanced disease. The primary end point was PFS; patients could cross over at the time of progressive disease after confirmation by a blinded IRC.[23][Level of evidence B1]
Source links and citations
An international multicenter trial (BREAK-3 [NCT01227889]) compared dabrafenib with dacarbazine. A total of 250 patients with unresectable stage III or IV melanoma and BRAF V600E pathogenic variants were randomly assigned in a 3:1 ratio to receive dabrafenib (150 mg by mouth daily) or dacarbazine (1,000 mg/m2 IV every 3 weeks). IL-2 was allowed as a previous treatment for advanced disease. The primary end point was PFS; patients could cross over at the time of progressive disease after confirmation by a blinded IRC.[23][Level of evidence B1]
With 126 events, the HR for PFS was 0.30 (95% CI, 0.18–0.51; P < .0001). The estimated median PFS was 5.1 months for dabrafenib versus 2.7 months for dacarbazine. OS data are limited by the median duration of follow-up and crossover. The partial response rate was 47% and the complete response rate was 3% in patients who received dabrafenib, compared with a partial response rate of 5% and a complete response rate of 2% for those who received dacarbazine.
An international multicenter trial (BREAK-3 [NCT01227889]) compared dabrafenib with dacarbazine. A total of 250 patients with unresectable stage III or IV melanoma and BRAF V600E pathogenic variants were randomly assigned in a 3:1 ratio to receive dabrafenib (150 mg by mouth daily) or dacarbazine (1,000 mg/m2 IV every 3 weeks). IL-2 was allowed as a previous treatment for advanced disease. The primary end point was PFS; patients could cross over at the time of progressive disease after confirmation by a blinded IRC.[23][Level of evidence B1]
The most frequent adverse events in patients treated with dabrafenib were cutaneous findings (i.e., hyperkeratosis, papillomas, palmar-plantar erythrodysesthesia), pyrexia, fatigue, headache, and arthralgia. Cutaneous SCC or keratoacanthoma occurred in 12 patients, basal cell carcinoma occurred in four patients, mycosis fungoides occurred in one patient, and new melanoma occurred in two patients.
Studies cited in this source section
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Preserved source evidence · Not medical advice