Teva Pharmaceutical announced that the U.S. FDA approved SYNRIBO for Injection to treat adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors. The indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO. It will be available for prescribing shortly. SYNRIBO received an accelerated approval that allows the FDA to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The approval is based on an analysis of combined data subsets from two Phase II, open-label, multicenter studies.
- Pharmaceuticals & Drug Trials
- Teva Pharmaceutical