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FDA grants broad label for GSK's momelotinib in myelofibrosis with anemia

Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.). The approval came a day before the Sept. 16 PDUFA date, which had been extended by three months in June to allow the agency to review recently submitted data. A rare blood cancer characterized by dysregulated JAK-signal transducer and resulting in splenomegaly and progressive anemia, myelofibrosis affects roughly 25,000 people in the U.S. ....

Gilead Sciences Inc , Incyte Corp , Gilead Sciences , Jak1 2 , Gsk Plc , Jak Inhibitors , Incyte Corp ,

Selecting Therapy for Steroid-Refractory Chronic GVHD

Dr Gooptu highlights how she selects therapy for a patient who is refractory to steroids for chronic GVHD and Dr Inyang notes the adverse events seen with these therapies. ....

A Team , Team Based Approach , Steroid Refractory Chronic , Graft Versus Host Disease , Graft Vs Host Disease , Chronic Gvhd , Gvhd Treatment , Steroid Refractory , Adverse Events , Side Effects , Bone Density ,

Evolving Treatment Armamentarium for Myelofibrosis

Key opinion leaders provide a broad perspective on the current treatment armamentarium available to patients diagnosed with myelofibrosis. ....

Treatment Armamentarium , Mf Cancer , Primary Myelofibrosis , Jak Inhibitors , Jak Inhibition , Jak Stat Pathway , Jak Stat , Allogeneic Transplant , Allogeneic Stem Cell Transplant ,