US regulators have issued a full green light for Novartis’ targeted skin cancer therapy Tafinlar/Mekinist, nearly two years after an accelerated approval was issued for the combination.
The US Food and Drug Administration has cleared the treatment for use in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma, as detected by an FDA-approved test.
According to to Novartis, Tafinlar (dabrafenib)/Mekinist (trametinib) is the first targeted therapy combination demonstrating more than two years overall survival in patients with the most aggressive form of skin cancer.
Full approval will allow the firm 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,” noted Bruno Strigini, president of Novartis Oncology.
Accelerated approval, granted by the FDA in January last year, was based on data from a Phase I/II study comparing the combo to dabrafenib monotherapy. It’s full green light comes after data from the Phase III COMBI-d and COMBI-v confirmed significant benefits regarding progression-free (PFS) and overall survival (OS).
In Combi-d, Tafinlar/Mekinist achieved a statistically significant OS benefit compared to Tafinlar monotherapy (median of 25.1 months vs 18.7 months), while median PFS was 9.3 months versus 8.8 months, respectively. In COMBI-v, median PFS was 11.4 months for the combo compared to 7.3 months for the vemurafenib arm.