Sanofi discontinues bone marrow cancer drug trials

Sanofi is to discontinue all clinical trials and cancel plans for regulatory filings of its investigational bone marrow cancer drug, fedratinib. After a thorough risk-benefit analysis, including consultation with the US FDA, the global pharma company decided that the risk to patient safety outweighed the benefit that fedratinib would bring to patients.

Fedratinib (SAR302503) is a novel, investigational JAK2 inhibitor that was under development by Sanofi Oncology for the treatment of the three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia.

"We are deeply disappointed to have to discontinue development of fedratinib, especially given the needs of this difficult-to-treat patient population and the earlier promise shown for this therapy, but patient safety is our top priority and drove this decision."

Tal Zaks, MD, PhD, VP, Head of Development and Interim Head of Sanofi Oncology.

Sanofi has notified investigators of all ongoing fedratinib trials, as well as health authorities, of its decision to halt the trials.