Puma Biotechnology Inc. said the European Commission approved its medicine Nerlynx months after the European Medicines Agency recommended that it be used as a treatment for breast cancer.
The medicine, also known as neratinib, is intended for adults with early breast cancer who have undergone surgery to reduce the risk of their disease coming back. Specifically, the medicine is meant for early stage hormone-receptor positive HER2- breast cancer.
Nerlynx is expected to be given for one year following treatment with Roche Holding AG's Herceptin, or trastuzumab.
The approval is backed by the results of a phase 3 clinical trial called ExteNET that showed that a higher number of patients who received Nerlynx did not see their disease return when compared to those that received placebo.
Nerlynx will become commercially available throughout Europe during 2019. The medicine is also approved in the U.S.