FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.
The SANRECO phase II trial of divesiran, a first-in-class siRNA, in 48 phlebotomy-dependent patients with polycythemia vera, met its primary endpoint and secondary endpoints. The 36-week, randomized, double-blind, placebo-controlled portion of the trial administered divesiran subcutaneously (6 mg/kg) every six weeks or every twelve weeks.
