FDA Grants Full Approval and Label Update for Ponatinib in CML and ALL

The U.S. Food and Drug Administration (FDA) has granted ponatinib (Iclusig) full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) for whom no other tyrosine kinase inhibitor therapy is indicated; and for the treatment of adult patients with T315I­–positive CML (chronic phase, accelerated phase, or blast phase) or … (leggi tutto)