FDA News

FDA grants priority review for Tafinlar/Mekinist for melanoma

The FDA has granted priority review status to supplemental new drug applications for combined use of dabrafenib and trametinib in treating adults with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, GlaxoSmithKline announced.

A Prescription Drug User Fee Act target date was assigned for Jan. 8, 2014 for the trametinib (Mekinist) supplement and Jan. 9, 2014 for dabrafenib (Tafinlar), according to a press release. Data from a randomized phase 1/2 study comparing dabrafenib-trametinib combination therapy with dabrafenib monotherapy in adults with BRAF V600E and V600K mutation positive metastatic melanoma were presented with the applications.

Using the drugs in combination is investigational and unapproved in any country. GlaxoSmithKline announced in February a European regulatory submission for the drug combination in adults with unresectable or metastatic melanoma with BRAF V600 mutation. That review is ongoing, the release said.

The FDA announced in May that it had approved dabrafenib and trametinib as monotherapies for treating patients with metastatic or unresectable melanoma.

The FDA has granted priority review status to supplemental new drug applications for combined use of dabrafenib and trametinib in treating adults with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, GlaxoSmithKline announced.

A Prescription Drug User Fee Act target date was assigned for Jan. 8, 2014 for the trametinib (Mekinist) supplement and Jan. 9, 2014 for dabrafenib (Tafinlar), according to a press release. Data from a randomized phase 1/2 study comparing dabrafenib-trametinib combination therapy with dabrafenib monotherapy in adults with BRAF V600E and V600K mutation positive metastatic melanoma were presented with the applications.

Using the drugs in combination is investigational and unapproved in any country. GlaxoSmithKline announced in February a European regulatory submission for the drug combination in adults with unresectable or metastatic melanoma with BRAF V600 mutation. That review is ongoing, the release said.

The FDA announced in May that it had approved dabrafenib and trametinib as monotherapies for treating patients with metastatic or unresectable melanoma.