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CTI BioPharma has withdrawn its application for marketing authorization of pacritinib (Enpaxiq) in the European Union, according to the European Medicines Agency’s Committee for Medicinal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]

Trial supports early treatment of lower-risk ET



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Prescription medications
Photo courtesy of CDC

Results from the ARETA trial suggest patients with essential thrombocythemia (ET) can benefit from early treatment even if they are not considered high-risk. In this phase 3 trial, non-high-risk patients were less likely to experience ET-related cardiovascular events or disease progression if they received extended-release anagrelide rather than... [Read Article]

Novel interferon appears safer than HU in PV



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Attendees at the 2016 ASH Annual Meeting
SAN DIEGO—Results of the PROUD-PV trial suggest ropeginterferon alfa-2b is safer than hydroxyurea (HU) for patients with polycythemia vera (PV).In this phase 3 trial, ropeginterferon alfa-2b demonstrated non-inferiority to HU with regard to complete hematologic response (CHR).Ropeginterferon alfa-2b also had a significantly better overall safety profile.Unlike the patients... [Read Article]

Pacritinib bests BAT despite study truncation



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John Mascarenhas, MD

The JAK2/FLT3 inhibitor pacritinib significantly reduces spleen volume and symptoms in patients with myelofibrosis and low platelet counts, compared to best available therapy (BAT), according to results of the PERSIST-2 trial. In this phase 3 trial, BAT included the JAK1/2 inhibitor ruxolitinib. And pacritinib demonstrated benefits over BAT despite a truncated trial.... [Read Article]

MPNs limit daily activities and ability to work



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Poster session at the
2016 ASH Annual Meeting

Many patients living with myeloproliferative neoplasms (MPNs) have a high burden of disease that affects their quality of life and limits their ability to work, according to research presented at the 2016 ASH Annual Meeting. Researchers conducted the first-ever international survey of MPN patients, including those... [Read Article]

Drug produces mixed results in myelofibrosis



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Micrograph showing MF

Two phase 3 trials have shown mixed results in myelofibrosis (MF) patients receiving the JAK inhibitor momelotinib, according to Gilead Sciences, Inc., the company developing the drug. In the SIMPLIFY-1 study, momelotinib proved non-inferior to ruxolitinib when it came to the study’s primary endpoint but not its key secondary endpoint. In the... [Read Article]

FDA grants priority review for midostaurin



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Mast cells

The US Food and Drug Administration (FDA) has granted priority review for the new drug application for midostaurin (PKC412) as a treatment for advanced systemic mastocytosis (SM) and newly diagnosed, FLT3-mutated acute myeloid leukemia (AML). The FDA has also accepted for review the premarket approval application for the midostaurin FLT3 companion diagnostic, which... [Read Article]