Posted by Michael Wonder on 01 Jul 2019
Puma Biotechnology submits a supplemental new drug application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer
1 July 2019 - Puma Biotechnology has submitted a supplemental new drug application to the U.S. FDA for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).
The application is supported by the results of the Phase III NALA trial, a randomised controlled trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer.
