FDA CRL - Immunomedics, Inc.

The FDA issued a Complete Response Letter (CRL) to Immunomedics, Inc. for its Biologics License Application (BLA 761115) for sacituzumab govitecan. The agency could not approve the application due to multiple deficiencies affecting product safety, purity, and potency, as outlined under 21 CFR 601.20(c). A pre-license inspection and subsequent communications revealed objectionable conditions at the Morris Plains, NJ manufacturing facility. Main violations included inadequate data and information to ensure consistent commercial production, insufficient support for testing strategies, lack of appropriate assay controls, and unvalidated shipping processes for key intermediates and drug product. Additionally, the proposed prescribing information and carton/container labeling did not conform to FDA regulations (21 CFR 201.56, 201.57). Required actions include satisfactorily resolving all manufacturing facility observations, providing comprehensive data and root cause analyses to address product quality issues, revising specifications, validating all manufacturing and shipping controls, updating all labeling to meet regulatory standards, and submitting a detailed safety update per 21 CFR 314.50(d)(5)(vi)(b). The proposed proprietary name, "Trodelvy," remains acceptable but must be resubmitted with the corrected application.