The FDA issued Immunomedics a complete response letter for a BLA seeking accelerated approval for its antibody-based breast cancer treatment, sacituzumab govitecan, for patients who have tried at least two prior treatments.
The problems cited in the CRL relate exclusively to chemistry, manufacturing and controls rather than the clinical trial programs, said Immunomedics’ senior director of investor relations, Chau Cheng.
The issues related to approvability “were exclusively focused on CMC matters, and no new clinical or preclinical data need to be generated. In addition, there will be no impact on our clinical trial programs,” Cheng said.
“The CRL was clearly unexpected as we felt we had fully addressed all the open questions during our interactions with the agency,” he said. “We continue to believe that all the issues are fully addressable.”