Immunomedics, a Morris Plains, New Jersey-based clinical-stage biopharmaceutical company with a focus on antibody-drug conjugates (ADCs), has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for manufacturing issues relating to its biologics license application seeking accelerated approval of its ADC, sacituzumab govitecan, a breast-cancer drug candidate.

“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,” said Michael Pehl, President and Chief Executive Officer of Immunomedics, in a January 17, 2019 statement. “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.”

Immunomedics is developing sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

Source: Immunomedics