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FDA lifts full clinical hold on pacritinib

HT Staff Read Article
Published: 01/06/17

Micrograph showing MF

The US Food and Drug Administration (FDA) has lifted the full clinical hold placed on all clinical trials conducted under the investigational new drug application for pacritinib, an oral kinase inhibitor being developed as a treatment for myelofibrosis (MF). The FDA placed the hold on pacritinib trials in February 2016 after results from 2 phase 3 trials, PERSIST-1 and PERSIST-2, showed excess mortality in patients who received pacritinib. [Read Article]

Trial supports early treatment of lower-risk ET

Jen Smith Read Article
Published: 12/20/16

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 placebo. Patients who received extended-release anagrelide were also less likely to become high-risk over time. [Read Article]

Novel interferon appears safer than HU in PV

Jen Smith Read Article
Published: 12/12/16

Photo by Zak Hubbard

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 who received HU, none of the patients on ropeginterferon alfa-2b developed secondary malignancies. [Read Article]

Pacritinib bests BAT despite study truncation

Erilyn Riley Read Article
Published: 12/09/16

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. The US Food and Drug Administration (FDA) placed PERSIST-2 on clinical hold in February 2016 . . . [Read Article]

MPNs limit daily activities and ability to work

Mark Fuerst Read Article
Published: 12/07/16

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 with myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET). [Read Article]



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