A nervous few weeks lie ahead for Incyte, awaiting the FDA’s verdict on its novel myelofibrosis treatment, ruxolitinib. Equity analysts widely anticipate approval and the company’s bumper $2bn market cap, albeit diminished over the last couple of months, suggests many investors are similarly hopeful.
Two successful phase III trials, a priority review and lack of any other regulator endorsed therapies for the often fatal and debilitating bone marrow cancer give ground for optimism. However there is certainly room for caution. The absence of evidence that ruxolitinib extends survival and its sometimes severe side effects, in particular anaemia, will be scrutinised by the FDA; surprisingly for such a novel agent the agency has not called an advisory committee to review the drug. Add to this the somewhat controversial decision this week by the influential New England Journal of Medicine to publish what at best can be described as a cautious review of the product, and jitters ahead of the decision look justified.