Merck KGaA Cancer Vaccine Stimuvax On Clinical Hold Due To Encephalitis, But AE Didn't Occur In Lead Indications
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck KGaA/Oncothyreon's cancer immunotherapy Stimuvax is on clinical hold while a case of encephalitis is investigated, but the event occurred in an exploratory study with a very different patient population and regimen than other trials for the vaccine, leaving room for hope that the lead Phase III trials may soon be back on track
You may also be interested in...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product
Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class