Zelboraf vemurafenib regulatory update

The U.K.'s NICE issued final appraisal determinations recommending the use of melanoma drugs Yervoy ipilimumuab from Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) and Zelboraf vemurafenib from Roche. NICE, which rebuffed Yervoy last year, now recommends Yervoy to treat advanced malignant melanoma in adults who have received prior therapy - its approved indication. NICE said BMS provided additional data supporting the overall survival (OS) benefit of Yervoy in the Phase III MDX0101-20 trial, but noted that clinical effectiveness beyond 56 months was still uncertain (see BioCentury, Oct. 17, 2011 & April 23, 2012).

NICE also now backs Zelboraf to treat patients with unresectable locally advanced or metastatic melanoma in patients who are BRAF V600-mutation positive, based on additional information submitted by Roche. In August, the committee requested additional information to clarify assumptions made in Roche's economic model (see BioCentury, Aug. 13). ...