FDA Lifts Clinical Hold on Medivation’s Pidilizumab

The FDA has lifted its partial clinical hold on Medivation’s Phase 2 Pidilizumab trial in patients with relapsed or refractory diffuse large b-cell lymphoma.

The agency had placed the hold to better understand the candidate’s mechanism of action after the company said PD-1 was not its target. Investigator documents have been revised to reflect that pidilizumab is not an anti-PD-1 antibody. The clinical hold did not pose any safety concerns, the company says.

Medivation will submit an amendment to the chemistry, manufacturing and controls section of the IND during the second quarter to cater to larger manufacturing lot sizes.

Patient enrollment will resume for the two-cohort study that will assess patients who have undergone an autologous stem cell transplant and for those who have received salvage chemotherapy.