- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Sanofi Dumps Bone Marrow Cancer Drug, Fedratinib
Risk of encephalopathy outweighs potential benefits (November 18)
Sanofi has announced the decision to halt all clinical trials and to cancel plans for regulatory filings with its investigational Janus kinase 2 (JAK2) inhibitor fedratinib.
After a risk–benefit analysis, including consultation with the FDA, the study investigators, and independent expert neurologists and neuro-radiologists, the company determined that the risk to patient safety outweighed the benefit that fedratinib would provide.
The decision follows recent reports of cases consistent with Wernicke’s encephalopathy in patients participating in clinical trials of fedratinib. The FDA directed Sanofi to put all studies of the drug on clinical hold while the company investigated these cases to ensure the safety of fedratinib for patients.
Fedratinib is an investigational JAK2 inhibitor that was under development for the treatment of the three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia.
Source: Sanofi; November 18, 2013.