Novartis’ targeted skin cancer combination therapy Tafinlar/Mekinist has been issued a green light by the European Commission.

The duo has been approved to treat adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, marking the first targeted therapy combo cleared in the EU for the most aggressive form of skin cancer.

Approval came on the back of two Phase III studies in which the Tafinlar (dabrafenib)/Mekinist (trametinib) combination showed a significant overall survival benefit compared to Tafinlar and Zelboraf monotherapies. 

Data from the COMBI-d study showed that patients taking the therapy achieved median overall survival of 25.1 months compared to 18.7 months for those in the Tafinlar monotherapy arm.

Amgen deal

Meanwhile, the Swiss drug giant has also inked a pact with US biotech Amgen to commercialise and develop pioneering neuroscience treatments.

Under the plans, the firm will work together on BACE inhibitor programmes 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. 

Novartis and Amgen will share responsibilities for development and commercialisation. 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 receives global co-development rights and commercial rights outside the US, Canada and Japan to the investigative molecules in Amgen's migraine portfolio.