European Commission authorises GSK’s Omjjara (momelotinib)
OJJAARA™ (momelotinib) Now Available from Onco360 For the Treatment of Intermediate or High-Risk Myelofibrosis (MF), Including Primary MF or Secondary MF [Post-Polycythemia Vera (PV) and Post- Essential Thrombocythemia (ET)], in Adults with Anemia
Sept 15 (Reuters) - British drugmaker GSK Plc (GSK.L) said on Friday the U.S. Food and Drug Administration had approved its oral therapy to treat anemia in patients with a type of bone marrow cancer called myelofibrosis.
JAK inhibitor combination therapies may bolster the efficacy of ruxolitinib (Jakafi) monotherapy in patients with myelofibrosis, although further phase 3 research is necessary to define the roles of these combinations and determine how certain patient subsets may benefit from these and other treatment approaches, according to Prithviraj Bose, MD.
GSK is going to have to wait a little longer to start delivering a return on its $1.9 billion oncology bet. The FDA has delayed its ruling on the blood cancer candidate momelotinib by three months to provide time to review recently submitted data.
PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE:GSK) today announced new 48-week data from the MOMENTUM phase III trial that showed a majority of patients treated with investigational momelotinib maintained their responses across key clinical measures including Total Symptom Score (TSS), Transfusion Independence (TI) rate, and Splenic Response Rate (SRR) in myelofibrosis patients previously treated with an approved Janus kinase (JAK) inhibitor. Additionally, new analyses from MOMENTUM showed that TI response with momelotinib at week 24 was associated with overall survival. These data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (10-13 December) in New Orleans.
Less than six months into the $1.9 billion acquisition of Sierra Oncology, GSK has started to explore the possibility of new indications for the deal centerpiece, JAK inhibitor momelotinib.
GSK has announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for momelotinib, a new oral treatment for myelofibrosis, which, if approved, could be the only medicine available to address myelofibrosis, including anaemia, symptoms, and splenomegaly.
GlaxoSmithKline (GSK) appear to be making some positive progress in their oncology department, with drugs for both myelofibrosis and endometrial cancer both looking promising.
UK-based GSK has announced that the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for momelotinib.