Nearly a year after surprise rejection, Immunomedics returns to FDA
As last Christmas approached, analysts anticipated a potential blockbuster from Immunomedics. Instead, they got pharma coal: a CRL.
Now, nearly a year after the FDA first spurned Immunomedics’ lead drug, the ADC biotech is returning to plead their case again. They have resubmitted their BLA, seeking accelerated approval for sacituzumab govitecan for triple-negative metastatic breast cancer.
Immunomedics said the FDA noted manufacturing issues in their rejection. Soon after, it emerged that the agency had previously cited them for a breach of data integrity in the months leading up to their PDUFA, although the publicly released report is heavily redacted and it remains unclear if the data breach was directly connected to the FDA rejection.
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