The European Medicines Agency has licensed the breast cancer drug Herceptin for use in the early stages of the disease by European regulators, the organization has announced. Completion of fast-track appraisal of the drug will happen "within weeks," it added.
The process to license the drug for early stage breast cancer began in February when Swiss manufacturer Roche submitted its application to the European authorities.
Herceptin (trastuzumab) is a therapeutic for HER2 protein overexpressing metastatic breast cancer. It is a therapy for women with metastatic breast cancer whose tumors have too much HER2 protein. For patients with this disease, Herceptin is approved for first-line use in combination with paclitaxel, and as a single agent for those who have received one or more chemotherapy regimens. It was approved by the U.S. FDA in 1998.