FDA issues CRL relating to sacituzumab govitecan BLA

In a filing with the Securities and Exchange Commission revealed yesterday, USA biotech Immunomedics (Nasdaq: IMMU) said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration for the Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

“We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients,” said Michael Pehl, president and chief executive of Immunomedics.

He continued:“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.”