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.
Regulatory
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.
MELANOMA TREATMENT TO BE PBS-LISTED
MSD has welcomed the Federal Government’s announcement that patients with the most deadly form of skin cancer – advanced melanoma – will be able to access the company’s anti-PD1 immunotherapy (pembrolizumab) on the PBS.