FDA Lifts Hold on Trial Assessing Novel Therapy in Pancreatic and Prostate Cancer

Bellicum Pharmaceuticals recently announced that the Food and Drug Administration (FDA) lifted a clinical hold on its phase 1/2 dose-escalation trial to evaluate its GoCAR-T product candidate BPX-601 in combination with rimiducid for the treatment of patients with previously treated metastatic pancreatic or prostate cancer.

The clinical hold, which orders a company to delay or suspend a trial, was placed on the dose-escalation trial in December 2020 after BPX-601’s manufacturer, Bellicum, alerted the FDA to the death of a patient enrolled on the trial. However, the investigator and manufacturer had reported the patient death was unrelated to treatment.

Since the hold was placed, the manufacturer has worked with the agency to address several requests. The FDA alerted Bellicum that it had satisfactorily addressed the issues and said the company can being enrolling patients again without any changes to the study protocol.

“I am pleased that our team was able to address the FDA’s clinical hold questions in a timely manner, enabling us to evaluate BPX-601 in a cohort of patients with previously treated metastatic prostate cancer,” Bellicum’s President and CEO Rick Fair said in a company-issued press release. “I remain optimistic about the safety and potential clinical benefit of our BPX-601 product candidate in these patients.”

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