Immunomedics received an FDA complete response letter last month tied to manufacturing concerns about its breast cancer antibody-drug conjugate. When pressed by analysts, company executives dodged questions of whether it stemmed from a preapproval inspection of its plant last year.
Now the FDA has released the Form 483 from the inspection showing big issues with data integrity at the Morris Plains, New Jersey, plant where sacituzumab govitecan is being made.
The highly redacted, 13-observation missive says that during the inspection, investigators discovered serious data integrity issues, including manipulation of bioburden samples, misrepresentation of a test procedure in the batch records and backdating of batch records, including the dates of analytical results.
The FDA said it was unable to determine whether data integrity issues may have affected earlier batches because Immunomedics “questioned plant personnel under “attorney/client privilege and no additional documentation is available.”
In addition to the data concerns, the form said among other things that raw material sampling was inadequate and records were not available to track their history. On top of that, there were issues over cleaning and the potential for contamination and more.
During the call with analysts last month, Immunomedics CEO Michael Pehl called the CRL “unexpected,” saying executives believe all issues are addressable for the breakthrough cancer treatment but refusing to provide any details about specifics until they meet with the FDA. He wouldn’t say whether the issues stemmed from the Form 483 issued in August or even if they were tied to the company’s manufacturing site in Morris Plains, New Jersey.
It was another in a string of upsets at the company. In May 2017, Seattle Genetics terminated a potential $ 2 billion development and licensing deal for sacituzumab govitecan after a shareholder revolt over the value of the deal. The fight led to the ouster of CEO Cynthia Sullivan and founder David Goldenberg.
The company responded by hiring Pehl—formerly of Celgene—as its CEO, who in turn brought on several former Celgene colleagues for key roles.