FDA lifts clinical hold on Merck KGaA's Stimuvax cancer vaccine study
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck KGaA and U.S. affiliate EMD Serono will resume two studies of experimental cancer immunotherapy Stimuvax (BLP liposome vaccine) in patients with non-small cell lung cancer after FDA partially lifted the clinical hold it placed on the entire Stimuvax program in March (1"The Pink Sheet" DAILY, March 23, 2010). A third study, STRIDE, in advanced breast cancer, remains on hold while Merck and the agency decide on next steps, Merck said June 17. The hold followed a case of encephalitis observed in a patient enrolled in an exploratory Phase II trial of the vaccine in patients with multiple myeloma. Protocol in the two NSCLC trials, START and INSPIRE, are being amended to add specific safety measures in response to the serious adverse event