GlaxoSmithKline reported that its Tafinlar (dabrafenib), an orally bioavailable BRAF inhibitorindicated for the treatment of patients with metastatic melanoma, has been approved by NHS England to be routinely funded by the CDF (Cancer Drugs Fund).
Tafinlar is now available for use in metastatic melanoma patients in England who satisfy certain specific criteria.
The usual available doses are 75mg and 150mg and the recommended dose is 150mg orally twice-daily taken at least one hour before or at least two hours after a meal.
Since the efficacy and safety of dabrafenib have not been established in patients with wild-type BRAF melanoma, dabrafenib should not be used in patients with wild-type BRAF melanoma.
The European Commission previously granted marketing approval for dabrafenib as an oral targeted treatment indicated in monotherapy for unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma that has spread to other parts of the body) in adult patients with a BRAF V600 mutation.
Dabrafenib is currently licensed in the EU as monotherapy for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation as detected by a validated test.
The efficacy of dabrafenib in the treatment of adult patients with BRAF V600 mutation positive unresectable or metastatic melanoma has been evaluated in three clinical studies (BRF113683 [BREAK-3], BRF113929 [BREAK-MB], and BRF113710 [BREAK-2]) including patients with BRAF V600E and/or V600K mutations.
Dabrafenib is currently under development for the treatment of solid tumours such as non-small cell lung cancer, colorectal cancer, BRAF mutated thyroid carcinoma and melanoma brain metastases.
Image: Pigmented malignant melanoma. Photo: courtesy of Nephron.