Roche's Herceptin OK for early use in EU, CHMP

Swiss drug major Roche says that the European Union's Committee for Human Medicinal Products has issued a positive recommendation for the use of Herceptin (trastuzumab), following surgery and standard chemotherapy, as adjuvant treatment of early-stage HER2-positive breast cancer, an aggressive tumor type with high relapse rates which requires immediate attention and affects approximately 20%-30% of breast cancer sufferers.

According to the Basle-headquartered firm, the CHMP's decision is based on results from the international HERA (HERceptin Adjuvant) study which showed that Herceptin, following standard chemotherapy, reduces the risk of cancer relapse 46% compared to chemotherapy alone. Roche noted that these "remarkable benefits" have also been seen in three other major global and US studies.

In the USA, Roche's development partner, majority-owned biotechnology group Genentech, filed a supplemental Biologic License Application for the use of Herceptin in this indication with the Food and Drug Administration in February and its application received a priority review designation.