The US Food and Drug Administration (FDA) rejected Immunomedics biologics license application (BLA) for its antibody-drug conjugate, sacituzumab govitecan, at the end of last month.
After the rejection, Immunomedics released little information regarding the FDA’s decision, only noting it was related to chemistry, manufacturing, and control matters.
The FDA has released its inspection report, while heavily redacted, reveals that data manipulation occurred and investigators noted “misrepresentation of the integrity test procedure in the batch record.”
The data integrity issue occurred in February 2018 but according to the inspectors, this did not trigger a deviation. The inspection itself was carried out between August 6 and August 14, 2018.
This analysis extended to suggest that there could be ‘no assurance’ that samples and batch records, as well as commercial batches manufactured prior to February 2018 had not also been impacted by the ‘data integrity breach.’
Further investigation into earlier time periods was hindered by attorney-client privilege, as interviews were carried out by Immunomedics on the matter, and therefore inspectors did not have access to additional document or access to make a pre-license inspection.
In total, the inspection raised 13 points for the New Jersey drug substance intermediate manufacturing facility. Additional issues raised included the lack of inventory audit trials procedures and inadequate design of the facility due to drains not being present in particular rooms.
The drug candidate, sacituzumab govitecan, is a treatment for metastatic triple-negative breast cancer patients who have received at least two prior treatments.
At the time of the initial complete response letter (CRL), Michael Pehl, CEO of Immunomedics, stated that the company would request a meeting to understand the requirements and timelines for approval.