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.

The agency’s approval was based on two phase 3 studies that demonstrated statistically significant progression-free survival and overall survival compared with monotherapy of dabrafenib or Zelboraf (vemurafenib, Genentech) in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma, the release reported.

Priority review for approval of the dabrafenib plus trametinib combination for BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test was granted by the FDA in July. The regular approval was based on survival data from the COMBI-d and COMBI-V phase 3 trials, according to the release.

“We’re inspired by the difference Tafinlar + Mekinist can make for patients battling such a serious disease as metastatic melanoma,” Bruno Strigini, president of Novartis Oncology, stated in the release. “This approval of the combination in the U.S. allows us to communicate more broadly with the melanoma community about the role of targeted therapies, our data, the possibility to improve clinical outcomes for patients and our commitment to develop these medicines to their fullest potential.”

In 2014, the FDA approved the combination of dabrafenib and trametinib in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test, according to the release. Phase 2 data through the FDA’s Accelerated Approval program was used for the initial approval, which was contingent on the results of the phase 3 COMBI-d study.

The most common adverse events reported with the dabrafenib plus trametinib treatment were pyrexia, nausea, rash, chills, diarrhea, headache, vomiting, hypertension, arthralgia, peripheral edema and cough, according to the release.

Reference: www.novartis.com