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GlaxoSmithKline submits FDA applications for Tafinlar/Mekinist to treat metastatic melanoma
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GlaxoSmithKline has submitted supplemental New Drug Applications to the FDA for BRAF inhibitor dabrafenib in combination with MEK inhibitor trametinib as therapy for metastatic or unresectable melanoma, the company announced today.
The FDA announced in May that it had approved dabrafenib (Tafinlar) to treat patients whose tumors express BRAF V600E gene mutation and trametinib (Mekinist) for patients whose tumors express BRAF V600E or V600K gene mutations. The drugs were not approved as combination therapy.
Data from a randomized phase 1-2 study comparing dabrafenib monotherapy with dabrafenib and trametinib in combination for treating patients with BRAF V600E and V600K mutation positive metastatic melanoma was used for the applications, according to today’s press release.
Dabrafenib/trametinib is not approved anywhere in the world, according to GlaxoSmithKline.
The marketing authorization application for trametinib, as monotherapy and in combination with dabrafenib, is undergoing European review, the release reported. The European Medicine Agency’s Committee for Medicinal Products for Human Use announced in June that it had recommended marketing authorization for dabrafenib for treating adults with metastatic or unresectable melanoma expressing BRAF V600 gene mutation.