Immunomedics Receives CRL From FDA For Sacituzumab Govitecan BLA

(RTTNews) - Immunomedics Inc., (IMMU) said it has received a Complete Response Letter from the U.S. Food and Drug Administration for the Biologics License Application seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer or mTNBC who have received at least two prior therapies for metastatic disease.

"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," said Michael Pehl, President and Chief Executive Officer of Immunomedics.