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The news of the rejection comes one month after the FDA released a new data integrity guidance to improve drug quality.
Exactly three months to the day after the U.S. Food and Drug Administration (FDA) cited biopharmaceutical company Immunomedics for its handling of a data integrity breach — among other violations — the FDA informed the company that its breast cancer treatment called sacituzumab was not granted accelerated approval.
The FDA issued a complete response letter to the company that focused exclusively on chemistry, manufacturing and control matters, according to Michael Pehl, president and CEO of Immunomedics.
“The (complete response letter) was clearly unexpected as we felt we had fully addressed all the open questions during our interactions with the agency,” Pehl said during a conference call to investors on Friday morning.
Pehl continued to reiterate that the issues are not clinical or preclinical, so no new data generation is required. He also added that the issues mentioned in the letter do not have to do with Immunomedics’ site in Morris Plains, N.J. and are not partner related.
But the drug substance manufacturing facility in N.J. is where the FDA observed the violations that occurred between August 6 and 14 last year.
According to the FDA’s December announcement of the data integrity breach, an investigation revealed that Immunomedics’ quality control unit did not have the authority to investigate critical deviations that took place on site. More specifically, the FDA mentioned the data integrity breach that happened in February of 2018 that did not trigger a deviation.
“This breach included manipulated bioburden samples, misrepresentation of an integrity test procedure in the batch record and backdating of batch records, such as dates of analytical results,” the notice said.
And the timing of the rejection news comes just one month after the FDA released a new data integrity guidance to improve drug quality and ensure the data associated with drug manufacturing are complete, consistent and accurate to ensure reliability.
Now, Immunomedics is focusing on the next step: talking with the agency to fully understand the issues and come up with a big plan for the fastest resubmission possible.
Immunomedics hopes that under breakthrough designation, the FDA will expedite the process.
Meanwhile, the biotech company felt it was on track to get its first drug approval in Immunomedics’ 37 years.
Its drug, sacituzumab, aims to be used for the treatment of patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.
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