
RegulatoryBusiness Wire
Vertex Pharmaceuticals Receives FDA Approval for Pozetaciclib in Essential Thrombocythemia
Vertex announces FDA approval of pozetaciclib for adults with essential thrombocythemia who are resistant or intolerant to hydroxyurea.
Vertex Pharmaceuticals today announced that the FDA has approved pozetaciclib for the treatment of adults with essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea. In Phase 3 trials, pozetaciclib demonstrated a statistically significant improvement in complete hematologic response rate compared to best available therapy. Pozetaciclib is a selective CDK2 inhibitor that targets the abnormal megakaryocyte proliferation in ET. This approval provides patients with hydroxyurea-resistant or intolerant ET a new oral treatment option.
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