Novartis nabs EU approval for melanoma-fighting cocktail bought from GSK

Novartis ($NVS) has been riding a wave of good fortune with its melanoma duo Tafinlar and Mekinist since picking up the duo from GlaxoSmithKline ($GSK), scoring a priority stateside review for the therapy in July. Now the company is adding another feather to its cap as European regulators gave their final signoff for the combo for patients with a deadly form of the disease.

The European Commission approved Tafinlar plus Mekinist for adults with unresectable or metastatic melanoma--the most aggressive form of the disease--who have a BRAF V600 mutation, Novartis said in a statement. Regulators based their approval on two Phase III studies, which found that the duo helped extend patients' lives and improved their odds of survival compared to Tafinlar by itself.

In the first study, patients who took both meds lived more than two years longer on average, compared with about a year and a half for individuals who took solo Tafinlar. And patients who took the combo had increased odds of survival, with a 74% chance after one year on the med and a 51% chance after two years. Patients who only received Tafinlar had a 68% chance of survival after one year and 42% chance after two years on the therapy.

The second study, which pitted the duo against Roche's ($RHHBY) BRAF-targeted drug Zelboraf, also turned in positive numbers for the med, with patients who took Novartis' combo therapy living longer than patients who took Zelboraf alone. The company plans to release data from the trial at an upcoming medical congress.

Novartis' Bruno Strigini

With promising numbers in tow, Novartis plans to make the duo available in Europe "as soon as possible," illustrating the company's "ongoing commitment to deliver medicines that can further enhance outcomes for patients with metastatic melanoma," Bruno Strigini, president of Novartis Oncology, said in a statement.

EU approval for its Tafinlar/Mekinist combo marks another win for Novartis, which has been riding high with its new oncology assets since shelling out $16 billion for GlaxoSmithKline's cancer portfolio last year in a multi-unit asset swap. The Swiss drugmaker is aiming to become a leader in melanoma meds, and the new approval helps the company along the way.

"We're seeing some very important advances in this area, and we believe our portfolio stacks up extremely well," Bill Hinshaw, EVP of Novartis' U.S. Oncology business, told FiercePharma at ASCO earlier this year.

But Novartis also wants to grow the entire portfolio that it picked up from GSK, which includes leukemia fighter Arzerra, and Votrient for kidney and soft tissue cancers. The company's new meds, along with tried-and true performers such as leukemia powerhouse Gleevec, follow-up leukemia med Tasigna and kidney cancer drug Afinitor could help the company deliver on its promise of becoming a leader in oncology.

- here's Novartis' statement
- read the Reuters brief

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