trending Market Intelligence /marketintelligence/en/news-insights/trending/ilz4iawqpx7yefiyml9leg2 content esgSubNav
In This List

Puma Biotechnology breast cancer drug approved in EU

Blog

Baird Research is Now Exclusively Available in S&P Global’s Aftermarket Research Collection

Blog

Japan M&A By the Numbers: Q4 2023

Blog

Essential IR Insights Newsletter Fall - 2023

Case Study

A Corporation Clearly Pinpoints Activist Investor Activity


Puma Biotechnology breast cancer drug approved in EU

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.

SNL Image

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.