IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI) today announced that it has received notice from the European Medicines Agency (“EMEA”) that it agrees with the overall clinical development plan, design and endpoints of the pivotal North American Phase 3 trials for EOquin, the Company’s lead drug candidate for non-invasive bladder cancer. Two Phase 3 protocols are open and currently recruiting patients in North America. The trial design was reviewed under a Special Protocol Assessment procedure with the FDA. The EMEA agrees that the current placebo-controlled studies as designed should be sufficient for a regulatory decision regarding European registration. Additionally, the EMEA indicated that, pending a review of the study outcomes, no additional safety data would be required for registration.
