Novartis announced that the FDA has granted priority review of the combination of Tafinlar and Mekinist for adults with unresectable or metastatic melanoma with a BRAF V600 mutation.
Regulatory
Regulatory Filings Move Dabrafenib/Trametinib Combo Closer to Full Melanoma Approval
The FDA has assigned a priority review to an application for the full approval of dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with unresectable or metastatic BRAFV600 mutation-positive melanoma, according to a statement from the drug’s developers, Novartis.
European Commission approves Keytruda for treating advanced melanoma
Merck announced that the European Commission has approved Keytruda for treating unresectable or metastatic melanoma in adults, according to a press release.
FDA Extends Cobimetinib Review Period in Advanced Melanoma
The FDA has extended the review period for the MEK inhibitor cobimetinib in combination with the BRAF inhibitor vemurafenib (Zelboraf) for patients with BRAFV600 mutation-positive advanced melanoma by 3 months, making the new decision date November 11, 2015.