ARTICLE | Clinical News

Tykerb lapatinib regulatory update

October 18, 2010 7:00 AM UTC

A panel from U.K.'s NICE rejected an appeal of a final appraisal determination (FAD) against Tyverb lapatinib from GlaxoSmithKline, but the agency said it will now reevaluate the breast cancer drug in a multi-technology appraisal with Herceptin trastuzumab (see BioCentury, July 19). NICE will not issue Tyverb guidance at this time but said it now believes a better way of assessing the value of Tyverb is to consider it alongside Herceptin in the post-progression setting, for which Herceptin is neither approved or recommended but nevertheless is frequently used, according to NICE. Tyverb is approved for advanced or metastatic HER2-positive breast cancer patients who have received prior therapy, while Herceptin is approved for first-line HER2-positive breast cancer. ...