Company again withdraws application for pacritinib



Primary myelofibrosis
CTI BioPharma has withdrawn its application for marketing authorization of pacritinib (Enpaxiq) in the European Union, according to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The company was seeking approval for pacritinib, a JAK2/FLT3 inhibitor, to treat splenomegaly or symptoms of myelofibrosis (MF) in adults... [Read Article]

CHMP recommends product for hemophilia B



Antihemophilic factor
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for nonacog beta pegol (N9-GP, Refixia®). N9-GP is an extended half-life factor IX molecule intended for replacement therapy in patients with hemophilia B. The CHMP has recommended N9-GP for use as prophylaxis, for on-demand treatment... [Read Article]

CHMP recommends drug for relapsed/refractory cHL



Pembrolizumab (Keytruda)
Photo courtesy of Merck
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the anti-PD-1 therapy pembrolizumab (Keytruda) as a treatment for patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The recommendation pertains specifically to adults with cHL who have... [Read Article]

New resource designed to help prevent CINV



Cancer patient
receiving chemotherapy
Photo by Rhoda Baer
The Hematology/Oncology Pharmacy Association (HOPA) has announced the release of a toolkit intended to help prevent chemotherapy-induced nausea and vomiting (CINV) in cancer patients. The Time to Talk CINV™ toolkit was designed to facilitate dialogue between patients and their healthcare teams to ensure no... [Read Article]

CHMP advocates approval of edoxaban product



Thrombus
Image by Andre E.X. Brown
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Roteas receive marketing authorization for the same indications as Lixiana. Both Roteas and Lixiana are oral factor Xa inhibitors that contain the active ingredient edoxaban. The CHMP has recommended approving Roteas for the... [Read Article]