Puma Biotechnology Inc. appealed the rejection of its breast cancer drug in the EU.
The company asked for a re-examination of the European Medicines Agency's negative opinion on Nerlynx.
Nerlynx, or neratinib, is indicated as an extended additional cancer treatment for early-stage human epidermal growth factor receptor 2-positive breast cancer. Human epidermal growth factor receptor 2 is a type of protein involved in normal cell growth and can be found on some cancer cell types.
The committee previously rejected the company's application for the breast cancer drug, citing how the medicine's benefits did not outweigh its risks.
