Medivation: FDA Lifts Partial Clinical Hold On Pidilizumab - Quick Facts

(RTTNews) - Medivation, Inc. (MDVN) announced the U.S. FDA has lifted the partial clinical hold on the Investigational New Drug application for pidilizumab in hematological malignancies and confirmed that the Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma, as well as other studies that cross reference the IND, may now proceed.

The company said it intends to submit an amendment to the Chemistry, Manufacturing and Controls section of the IND in the second quarter to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for pidilizumab.