Tafinlar/Mekinist, a targeted skin cancer combination therapy from Swiss drug giant Novartis, has been approved by the European Commission.
The tandem has been green-lighted to treat adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, making it the first targeted therapy combo cleared in the E.U. for the most aggressive form of skin cancer.
The approval comes in the wake of two Phase III studies in which the Tafinlar (dabrafenib)/Mekinist (trametinib) combo showed a significant overall survival benefit as compared to Tafinlar and Zelboraf monotherapies.
Results from the COMBI-d study revealed that patients who took the therapy achieved a median overall survival of 25.1 months, compared to 18.7 months for patients in the Tafinlar monotherapy arm.
Separately, Novartis has signed a deal with California-based biotech Amgen to commercialize and develop pioneering neuroscience treatments.
The companies will work together on BACE inhibitor programs in Alzheimer's disease, with Novartis' oral therapy CNP520 the lead molecule, and migraine, including Amgen’s Phase III AMG 334 and Phase I AMG 301.
The two firms will share responsibility for development and commercialization. Amgen will pay an upfront fee and milestone payments, as well as disproportional R&D costs for an agreed-upon period, followed by a 50/50 cost/profit share arrangement.
For the compounds in the migraine field, Novartis will receive the global co-development rights—and commercial rights outside the U.S., Canada and Japan—to the investigative molecules in Amgen's migraine portfolio.