The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. If approved in the EU, ruxolitinib could provide the first targeted treatment option for these patients.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
