FDA Accepts sNDA for Neratinib Combo for HER2+ Breast Cancer

Sep 11, 2019 – The FDA has accepted a supplemental new drug application (sNDA) for neratinib for use in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed at least 2 prior lines of HER2-directed treatments. The sNDA is based on data from the phase III NALA trial, which showed that the combination of neratinib and capecitabine reduced the risk of disease progression or death by 24% compared with … (leggi tutto)