NICE recommends Yervoy, Zelboraf for melanoma
The U.K.'s NICE issued two final appraisal determinations (FADs) on Thursday recommending the use of melanoma drugs Yervoy ipilimumuab from Bristol-Myers Squibb Co. (NYSE:BMY) and Zelboraf vemurafenib from Roche (SIX:ROG; OTCQX:RHHBY). NICE, which rebuffed Yervoy last year, now recommends Yervoy to treat advanced malignant melanoma in adults who have received prior therapy -- its approved indication. The committee said BMS provided additional data that supported the overall survival benefit of Yervoy in the Phase III MDX0101-20 trial (see BioCentury Extra, Oct. 13, 2011).
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 Extra, Aug. 9). ...