WILMINGTON, Del.–(BUSINESS WIRE)–Mar. 23, 2023– Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD). The complete response letter states that the FDA […]

Mar 9, 2023 Ashling Wahner Treatment with ruxolitinib impaired antibody responses to complete vaccination with the BNT162b2 SARS-CoV-2 vaccine in patients with myelofibrosis or polycythemia vera. Treatment with ruxolitinib (Jakafi) impaired antibody responses to complete vaccination with the BNT162b2 SARS-CoV-2 vaccine in patients with myelofibrosis or polycythemia vera (PV), according to findings from a prospective, […]

March 3, 2023 at 4:35 PM EST Independent data monitoring committee advises study unlikely to meet primary endpoint, leading to decision to discontinue the study WILMINGTON, Del.–(BUSINESS WIRE)–Mar. 3, 2023– Incyte (Nasdaq:INCY) today announced that it will discontinue the Phase 3 LIMBER-304 trial following results of a pre-planned interim analysis conducted by an independent data monitoring committee […]

Independent data monitoring committee advises study unlikely to meet primary endpoint, leading to decision to discontinue the study March 03, 2023 04:35 PM Eastern Standard Time WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that it will discontinue the Phase 3 LIMBER-304 trial following results of a pre-planned interim analysis conducted by an independent data monitoring committee […]

Purpose In this study, researchers want to find the highest dose of the drug abemaciclib that can be given safely with ruxolitinib in people with myelofibrosis that has developed on its own (primary myelofibrosis) or as a complication of the blood diseases polycythemia vera or essential thrombocythemia. In people with myelofibrosis, the bone marrow is […]

August 21, 2022 Kristi Rosa Targeted Therapies in Oncology, August 2022, Volume 11, Issue 11 Results from the MANIFEST study of pelabresib and ruxolitinib in myelfibrosis are positive. The phase MANIFEST-2 study continue to explored the combination in JAK inhibitor–naïve patients with myelofibrosis. The combined use of pelabresib (CPI-0610) and ruxolitinib (Jakafi) demonstrated durable responses beyond week 24 […]

On September 22, 2021, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Efficacy was evaluated in REACH-3 (NCT03112603), a randomized, open-label, multicenter clinical trial of ruxolitinib compared to best […]

American Journal of Hematology   Published July 31, 2021 COVID–19, the disease caused by pandemic SARS–CoV–2 infection, had significant impact on patients with hematologic conditions; a meta–analysis involving 3,377 patients with hematologic malignancies who were affected by COVID–19 reported a mortality rate of 34%. A similarly dismal outcome was documented among 175 patients with chronic myeloproliferative […]

Oncology Learning Network When initiated early in the course of the disease, decitabine with or without ruxolitinib has shown clinical benefit in patients with advanced phases of myeloproliferative neoplasms (MPNs; Acta Haematol. 2021;144[1]:48-57). “Treatment options are limited for patients with advanced forms of [MPN] including blast-phase disease (MPN-BP). Decitabine has frequently been deployed but its […]

Low-dose ruxolitinib (Jakafi) appears effective as treatment of patients with myelofibrosis (MF), improving splenomegaly and symptoms with a daily dose ≤ 10 mg, according to findings from a retrospective analysis. While the high-dose group had better outcomes to therapy, the difference in spleen length reduction between high-dose group and low-dose group was minimized. This ultimately […]