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ARTICLE | Company News

NICE rebuffs Perjeta

August 6, 2013 12:00 AM UTC

The U.K.'s NICE issued Perjeta pertuzumab from Roche (SIX:ROG; OTCQX:RHHBY) for its approved indication. In March, the European Commission approved Perjeta in combination with the pharma's Herceptin trastuzumab and docetaxel to treat HER2-positive metastatic or locally recurrent unresectable breast cancer in patients who have not received previous anti- HER2 therapy or chemotherapy. NICE said the magnitude of the overall survival (OS) benefit of Perjeta when added to Herceptin and docetaxel was "uncertain" because the OS data from the Phase III CLEOPATRA trial were "immature." As a result, the committee said Roche's OS estimate produced an incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) that was "outside the range normally considered as a cost-effective use of NHS resources."

Roche submitted interim OS data from the Phase III CLEOPATRA trial after 267 deaths occurred. The median OS had not yet been reached in the Perjeta arm vs. 37.6 months for Herceptin plus docetaxel (HR=0.66, p=0.0008). Final OS data are expected after about 385 deaths. The pharma could not be reached for a timeline on when the data are expected. ...