Sanofi ditches late-stage bone marrow cancer drug [ BeritaTerkini ]

<div id="yom-ad-LREC" class="yom-ad yom-ad-LREC"> <center> <div id="yom-ad-LREC-iframe" class="yom-ad"></div> </center> </div> <p><br></p> <div class="body-slot-container"> <div class="body-slot-mod"> <div class="yom-remote"> <div class="yom-loading" id="mediacontentrelatedstory_container"></div> </div> </div> </div> <p>PARIS (Reuters) – Sanofi has halted all clinical trials and cancelled plans to seek regulatory approval of fedratinib, a drug in late-stage development against rare bone marrow cancers, due to safety concerns.</p> <p>The decision follows recent reports of cases consistent with the neurological disorder Wernicke’s encephalopathy in patients in the fedratinib trials, the French drugs group said in a statement on Monday.</p> <p>Fedratinib is a so-called JAK2 inhibitor medicine that was in final Phase III tests for treating myelofibrosis, a rare cancer of the bone marrow. The disease can occur in people with no history of bone marrow problems – in which case it is called primary myelofibrosis – and also in people who have essential thrombocythaemia or polycythaemia vera.</p> <p>Industry analysts had penciled in relatively modest financial forecasts for the specialist oncology medicine, with sales of $ 226 million seen in 2017, following an expected launch in 2014, according to consensus forecasts compiled by Thomson Reuters Pharma.</p> <p>The U.S. Food and Drug Administration (FDA) directed Sanofi to put all fedratinib trials on clinical hold while the company thoroughly investigated the cases of Wernicke’s encephalopathy.</p> <p>Sanofi said it took immediate action requesting that study investigators discontinue fedratinib treatment for patients in the trials.</p> <p>Patients in fedratinib trials should consult with their treating physician to determine the best alternative course of therapy for their myelofibrosis, it said.</p> <p>(Reporting by Dominique Vidalon and Ben Hirschler; Editing by Louise Ireland)</p> <ul id="topics" class="hidden"> <li>Health</li> <li>Pharmaceuticals & Drug Trials</li> <li>Sanofi</li> <li>bone marrow</li> <li>clinical trials</li> </ul><p></p> //<!--[CDATA[ jQuery(".gmframe").load(function (){jQuery(this).remove();}); //]]--> <br><br>

Sanofi ditches late-stage bone marrow cancer drug [ BeritaTerkini ]

PARIS (Reuters) – Sanofi has halted all clinical trials and cancelled plans to seek regulatory approval of fedrati...

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