FDA Issues Complete Response Letter for Sacituzumab Govitecan in TNBC

January 18, 2019 – The FDA has issued a complete response letter to Immunomedics regarding its biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior therapies, citing chemistry, manufacturing, and control matters. “We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients,” said Michael Pehl … (leggi tutto)