Sanofi discards blood cancer drug in late-stage
pharmafile | November 19, 2013 | News story | Research and Development, Sales and Marketing | Sanofi, Wernicke's encephalopathy, fedratinib
Sanofi has scrapped its regulatory filing plans and late-stage trials for rare bone marrow cancer treatment fedratinib.
The reason given for the French firm to pull the plug on JAK2 inhibitor fedratinib during Phase III trials, follows consultation with the FDA and the treatment’s related risk to patients developing Wernicke’s encephalopathy – a neurological disorder.
Sanofi’s head of Development and Oncology Tal Zaks, said: “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.”
Sanofi determined that the risk to patient safety outweighed the benefit that fedratinib – which is also known as SAR302503 – would bring to patients.
The firm is not having a great year, as was also highlighted in June when it announced consigning another two investigational drugs to the corporate dustbin by dropping benzamide iniparib and injectable factor Xa inhibitor otamixaban, after Phase II and III trial failures.
According to Reuters, analysts had predicted tidy financial forecasts for fedratinib with sales of $226 million likely in 2017, following its expected launch in 2014.
Fedratinib was being developed for the treatment of the three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia.
Brett Wells
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