NICE rebuffs Tyverb, Herceptin in combination with aromatase inhibitors
The U.K.'s NICE issued draft guidance recommending against Tyverb lapatinib or Herceptin trastuzumab in combination with an aromatase inhibitor as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Tyverb, while Roche (SIX:ROG; OCTCQX:RHHBY) markets Herceptin. NICE said the combinations' overall survival (OS) benefit is "uncertain" compared to existing treatments. The guidance reiterates a final appraisal determination (FAD) issued last June, which Roche appealed.
The pharma argued in its appeal that the Herceptin combination met the small population criteria within NICE's end-of-life criteria. In November, an independent panel upheld Roche's appeal. NICE subsequently revised the draft to state that Herceptin plus an aromatase inhibitor fulfills the small patient population criteria. However, the committee said the combination still does not meet its end-of-life criteria because its population does not meet the criteria for short life expectancy. Comments on the draft are due March 6 (see BioCentury Extra, June 30, 2011). ...