The firm was seeking a new indication for Tyverb (lapatinib), in
combination with paclitaxel, for patients with metastatic breast cancer whose
tumours over-express HER2.
The decision follows an assessment from the Committee for Medicinal
Products for Human Use (CHMP) this week.
It said that the lack of a direct comparison to Roche’s established HER2
breast cancer drug Herceptin (trastuzumab), plus paclitaxel, “hampered the
proper assessment of the benefit-risk in European patients in the applied
indication”.