Recent FDA actions involving melanoma

Recent FDA actions reported on Healio.com/Dermatology include the agency’s approval of Opdivo as monotherapy for treatment-naïve BRAF wild-type melanoma.

Other actions include the regular approval of Tafinlar/Mekinist for BRAF V600 mutation-positive melanoma based on long-term survival:

FDA approves Opdivo for advanced, treatment-naive BRAF wild-type melanoma

The FDA approved nivolumab as monotherapy for treatment-naive, BRAF wild-type unresectable or metastatic melanoma.

Jeffrey S. Weber

“This important news means that we now have another new option to offer patients with BRAF wild-type metastatic melanoma,” Jeffrey S. Weber, MD, PhD, deputy director of Laura and Isaac Perlmutter Cancer Center at NYU Langone Medical Center, said in a press release. Read more

FDA approves Tafinlar/Mekinist for BRAF V600 mutation-positive melanoma based on long-term survival

Novartis announced in a press release that the FDA has given regular approval for Tafinlar plus Mekinist for treating patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma.

The combination of Tafinlar (dabrafenib), a BRAF inhibitor, and Mekinist (trametinib), a MEK 1/2 inhibitor, is the first targeted therapy combination that demonstrated more than 2 years overall survival in patients with the aggressive form of skin cancer, according to the release. Read more

FDA requests more data for Opdivo in treating BRAF V600 mutation-positive melanoma

Bristol-Myers Squibb announced that the FDA has requested additional data in its response to its supplemental biologics license application for Opdivo as monotherapy for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

The FDA issued a complete response letter for the supplemetal biologics license application to Bristol-Myers Squibb indicating the need for additional data in the patient population with the BRAF mutation, according to a press release. Read more

FDA approves Cotellic as part of combination regimen for advanced melanoma

The FDA today approved cobimetinib to be used in combination with vemurafenib for the treatment of advanced melanoma.

The cobimetinib (Cotellic, Genentech) and vemurafenib (Zelboraf; Genentech, Daiichi-Sankyo) treatment regimen is intended for patients with BRAF V600E- or V600K-positive melanoma whose disease has metastasized or cannot be removed by surgery. Read more