Marketing Application for Early Stage Breast Cancer Therapy Neratinib Submitted to EMA by Puma Biotechnology

Marketing Application for Early Stage Breast Cancer Therapy Neratinib Submitted to EMA by Puma Biotechnology
Puma Biotechnology has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for neratinib, an investigative tyrosine kinase inhibitor for the extended treatment of HER2-positive early stage breast cancer previously treated with trastuzumab (Herceptin)-based adjuvant therapy. Los Angeles-based Puma's application to the EMA was based on the results of the ExteNET Phase 3 clinical trial that met its primary endpoint of neratinib showing a statistically significant reduction in the risk of invasive disease recurrence or death compared with a placebo. "Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need for further improvement in outcome in order to attempt to further reduce this risk of recurrence following trastuzumab therapy," said Puma President and CEO Alan H. Auerbach in a press release"Neratinib may be able to provide this type of improvement to further help the patients with this disease. Auerbach said Puma is looking forward to working with the CHMP/EMA as they review the submission, which marks the first step in a global registration plan for the drug candidate
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