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FDA grants priority review of Tafinlar/Mekinist for adults with BRAF V600 mutation-positive melanoma
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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.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency also has adopted a positive opinion for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for treating the patient population, according to a press release.
“The CHMP positive opinion and FDA priority review of Tafinlar and Mekinist validate the importance of this targeted therapy combination for patients with the most serious form of skin cancer,” Bruno Strigini, president, Novartis Oncology, said in the release. “This good news for the combination of Tafinlar and Mekinist in metastatic melanoma follows on the FDA's recent Breakthrough Therapy designation for the combination in BRAF V600 mutation-positive non-small cell lung cancer. We look forward to working with the U.S. and EU regulatory authorities to help bring this targeted therapy combination to more patients who may benefit.”
The FDA and the CHMP based their decisions on data from the phase 3 COMBI-d and COMBI-v studies.
The COMBI-d study results showed the combination of dabrafenib and trametinib achieved a statistically significant overall survival (OS) benefit compared to dabrafenib monotherapy (median of 25.1 months vs 18.7 months; hazard ratio = 0.71 (95% CI, 0.55-0.92), according to the release.
Results of the COMBI-v study showed that the combination of dabrafenib and trametinib had significant OS benefit compared to Zelboraf (vemurafenib, Genentech) monotherapy (median for the combination not reached vs 17.2 months; HR=0.69 (95% CI, 0.53-0.89). OS at 1 year was 72% for the combination treatment compared with 65% of patients receiving vemurafenib, according to the release.
There were no new safety concerns observed in the combination, the most common adverse events including pyrexia, fatigue, nausea, headache, chills, diarrhea, rash, arthralgia, vomiting, hypertension and cough, the release stated.
In January 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.
The European Commission will review the CHMP recommendation with an expected decision within 3 months, which will apply to all 28 EU member states plus Iceland, Norway and Liechtenstein, according to the release.
Reference: www.novartisoncology.com