Swiss regulators have approved Cotellic (cobimetinib) for use in combination with Roche’s Zelboraf (vemurafenib)as a treatment for patients with advanced melanoma.
The Swissmedic decision marks the first approval for the selective MEK inhibitor, which is being developed by its discover, the California biopharma company Exelixis, and Roche.
Its Swiss approval was based on a phase III trial of 495 patients with untreated unresectable metastic melanoma that showed those receiving Cotellic and Zelboraf had, on average, a progression-free survival rate of over a year longer than those treated with Zelboraf alone.
Michael Morrissey, president and CEO of Exelixis, said: “The Swiss regulatory approval of cobimetinib is an important advance for melanoma patients, physicians, and caregivers.
“Exelixis congratulates our partner Roche on the first approval for the product, and we look forward to additional regulatory decisions in the United States and European Union, which are anticipated later this year.
Peak-year sales of the drug have been predicted to approach $800m and a regulatory decision on its European licence application is expected before the end of the year.
In the US, where Exelixis will be co-promoting the drug with Roche’s Genentech unit, a decision from the FDA on Cotellic – currently only its brand name in Switzerland – is due by 11 November.
Under the terms of the agreement, Exelixis is to receive an equal share of profits and losses for the first $200m of US sales, which decreases to 30% of profits from US sales over $400m. Additionally Exelis is to receive royalties on sales of cobimetinib outside the US.
For Roche the addition of Cotellic to Zelboraf could be an important one. The older drug has been until intense pressure from competitors such as Bristol-Myers Squibb’s (BMS) Yervoy (ipilimumab) and GSK’s Tafinlar(dabrafenib), and Zelboraf sales in the first six months of this year fell 25% to CHF 106m compared to 2014.
That competition is only expected to get harder thanks to new PD1 inhibitors like Ono Pharmaceutical/BMS’ Opdivo (nivolumab) and Merck & Co’s Keytruda (pembrolizumab).
Meanwhile, Roche and Exelixis are also currently investigating the effects of a triple combination therapy of Zelboraf, cobimetinib, and XL888, an HSP90-inhibitor which was able to achieve a 92% objective response rate in early phase I trials.