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Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand, 2013.
Dabrafenib is an orally bioavailable inhibitor of mutant BRAF protein in patients with melanoma.
On May 29, 2013, the U. S. Food and Drug Administration (FDA) approved dabrafenib (TAFINLAR™ capsule, GlaxoSmithKline, LLC), for the treatment of patients with non-operable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Concurrent with this action, FDA approved the THxID BRAF assay (bioMerieux, Inc.) for detection of BRAF V600E.
The company has also filed a Marketing Authorisation Application with the European Medicines Agency (EMA) for dabrafenib for treating adult melanoma patients with the same mutation. This regulatory application is currently under review (June 2013).
Dabrafenib is a selective BRAF inhibitor characterised by high response rates, a rapid mode of action, little toxicity, and a prolonged progression-free survival (PFS) over chemotherapy.
Key efficacy findings are summarised in the table below.
|No. of melanoma patients||156|
|No. BRAFV600E positive||131|
|No. BRAFV600K positive||18|
|No. With non-V600 BRAFmut||4|
|Response rate (% patients)||56 (V600E); 22 (V600K); 0 (other)|
|Progression free survival (months)||5.5 (each for V600E and V600K mutations)|
|Cutaneous SCC/KA||11% patients|
|No. of melanoma patients||92|
|No. BRAFV600E positive||76|
|No. BRAFV600K positive||16|
|No. with non-V600 BRAFmut||0|
|Response rate (% patients)||60 (V600E); 13 (V600K)|
|Progression free survival (months)||6.2 (V600E); 4.6 (V600K)|
|Cutaneous SCC/KA||9% patients|
|Dabrafenib (n = 187)||Dacarbazine (n = 63)|
|Confirmed tumour responses|
|Objective response rate||52% (95% CI 44, 59)||17% (95% CI 9, 29)|
|Complete response||6 patients (3%)||0|
|Partial response||91 patients (48%)||11 (17%)|
|Median duration of response||5.6 months||Not reached|
|Progression free survival (PFS) [investigator assessed]|
|Median, months (95% CI)||5.1 (4.9, 6.9)||2.7 (1.5, 3.2) [HR 0.3; p >0.0001]|
|IRC assessed PFS, median, months||6.7||2.9 (HR 0.35; 95% CI 0.2, 0.61)|
|Overall survival (months)||Not available||Not available|
|Cutaneous SCC/KA (all grades)||7||0|
|Pyrexia (grade 3)||3||0|
|No. of melanoma patients||172|
|No. in cohort A||89|
|No. BRAFV600E positive||139|
|No. BRAFV600K positive||33|
|No. with non-V600 BRAFmut||0|
|Response rate (% patients)||31–36 (V600E); 7–22 (V600K)a|
|Overall Survival (months)||7.1–7.6 (V600E); 3.7–5.1 (V600K)|
|Progression free survival (months)||3.7 (V600E); 1.8–3.7 (V600K)|
|Cutaneous SCC/KA||5% patients|
|Pyrexia (grade 3)||6% patients|
a: investigator-assessed intracranial response rate
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