Vertex Pharmaceuticals Receives FDA Approval for Pozetaciclib in Polycythemia Vera

Vertex Pharmaceuticals today announced that the FDA has approved pozetaciclib for the treatment of adults with polycythemia vera (PV) who are resistant or intolerant to hydroxyurea. In Phase 2 and 3 trials, pozetaciclib demonstrated significant hematocrit control and reduction in JAK2 V617F allele burden. Pozetaciclib is a selective CDK2 inhibitor that targets the abnormal cell proliferation in PV. This approval provides patients with hydroxyurea-resistant or intolerant PV a new oral treatment option.