Sesen Bio trial marred by misconduct — report; Bristol Myers picks up development of AI outfit's immunology drug
Sesen Bio said that it was not expecting a CRL from the FDA for its bladder cancer candidate Vicineum. But the rejected filing included thousands of violations and investigator misconduct, STAT News reported Wednesday.
The 130-patient study had more than 2,000 violations, 215 of which were classified as major, STAT said. Independent monitors also reported three investigators to the FDA for a “serious noncompliance” that “placed subjects at risk of harm.” A patient died in 2016 of liver failure related to the drug, and two years later, the company said that there were no drug-related deaths at a urology conference.
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