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, president and chief executive officer of Immunomedics. “The issues related to approvability in the CRL were exclusively focused on chemistry, manufacturing and control matters and no new clinical or preclinical data need to be generated. We are going to request a meeting with the FDA as soon as possible to gain a full understanding of the agency’s requirements and timelines for approval and we will work closely with the FDA with the goal of bringing this important medicine to patients as soon as possible.”
The FDA previously granted a priority review designation to the BLA for sacituzumab govitecan in July 2018. The FDA was scheduled to make its decision on the application by January 18, 2019.
... to read the full story