Exelixis’ Melanoma Drug Receives Swiss Approval for Use in Combination With Zelboraf

Swiss regulators have approved Exelixis’ cobimetinib for use in combination with Genentech’s Zelboraf to treat advanced melanoma — allowing the company to begin marketing the drug while it awaits regulatory decisions in the U.S. and EU.

Marketed under the trade name Cotellic, cobimetinib was discovered by Exelixis and developed with Genentech.

Genentech filed an NDA with the FDA in December 2014, receiving a PDUFA date of Nov. 11. Parent company Roche filed for marketing authorization with the European Medicines Agency in late 2014, and anticipates a decision by the end of this year.

The approval was based on a Phase 3 trial of cobimetinib with Zelboraf (vemurafenib) in 495 patients with advanced melanoma. Patients receiving the combination therapy lived more than 12 months without disease progression, compared with seven months for patients getting Zelboraf alone. Data from the trial was also submitted to the FDA and EMA.

Under terms of the collaboration, Exelixis will receive royalties on sales of cobimetinib outside the U.S. If it receives FDA approval, Exelixis and Genentech will equally share U.S. profits or losses, while Genentech’s share will decrease as sales increase.

Exelixis says it is focusing most of its development and commercialization efforts on its wholly owned renal cell cancer drug cabozantinib, which last week received breakthrough designation from the FDA. — Kellen Owings