Sanofi ends Phase III cancer drug
Sanofi has axed Phase III myelofibrosis drug fedratinib. Reports of encephalopathy among clinical trial patients prompted the decision. The drugmaker said in a statement Monday that it was stopping all clinical trials of the JAK2 inhibitor and will not pursue regulatory filings. Sanofi said it idled the clinical trials after the FDA requested a hold.
Pulling the drug from its pipeline means the French drugmaker is poised to enter the new year with an experimental oncology portfolio comprised of only Phase I and Phase II contenders. The Phase II pipeline is stacked with a PI3K inhibitor that is being tested for indications such as breast cancer, solid tumors and lymphoma, a dual PI3K/MTOR inhibitor, and two monoclonal antibodies.
Monday's news follows last week's muted enthusiasm for an FDA panel's Lemtrada endorsement. The advisory panel gave the drug the all-clear, despite concerns about clinical trial integrity, a cancer signal, and anticipated REMS monitoring difficulties, among others.