EMEA agrees strategy for Spectrum's EOquin

US cancer drug specialist Spectrum Pharmaceuticals 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 III trials for EOquin (apaziquone for intravesical instillation), the company's lead drug candidate for non-invasive bladder cancer.

Two Phase III protocols are open and currently recruiting patients in North America. The trial design was reviewed under a Special Protocol Assessment procedure with the US Food and Drug Administration. The EMEA agrees that the current placebo-controlled studies as designed should be sufficient for a regulatory decision regarding European registration. Additionally, it has indicated that, pending a review of the study outcomes, no additional safety data would be required.

Rajesh Shrotriya, chief executive of Spectrum, said: "this is a significant advancement for the EOquin program, as the advice indicates that we will not be required to repeat the current North American studies in Europe for registrational purposes. Having a defined registration path in Europe, where the incidence and prevalence of bladder cancer is about double that in the USA, makes EOquin an even more attractive licensing candidate for potential global partners that seek to serve this large and underserved patient population."