HQ Team
September 17, 2023: The USFDA has approved GSK Plc’s oral therapy to treat anaemia in patients with myelofibrosis, a type of bone cancer.
GSK’s momelotinib therapy, branded as Ojjaara, is used for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, in adults with anaemia.
The British drugmaker’s once-a-day oral therapy is the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that addresses the key manifestations of the disease.
Momelotinib is currently not approved in any other market. The FDA approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy, according to a GSK statement.
The conditions include anaemia, fatigue, night sweats, bone pain, and an enlarged spleen.
FDA extension
The USFDA had extended its approval for momelotinib by three months in June citing reviewing of additional data as a reason.
Myelofibrosis causes extensive scarring in bone marrow, leading to severe anaemia that can cause weakness and fatigue.
Bone marrow scarring can also result in the lowering of blood-clotting cells called platelets, which increases the risk of bleeding. Myelofibrosis often causes an enlarged spleen.
The rare blood cancer affects approximately 25,000 people in the US.
“The vast majority of myelofibrosis patients eventually develop anaemia, causing them to discontinue treatments and require transfusions,” said Nina Mojas, Senior Vice President, of Oncology Global Product Strategy, GSK.
“Given this high unmet need, we are proud to add Ojjaara to our oncology portfolio and address a significant medical need in the community.”
Anaemia over time
About 40% of patients have moderate to severe anaemia at the time of diagnosis, and nearly all patients are estimated to develop anaemia over the course of the disease.
Physicians have had limited treatment options to treat myelofibrosis patients with anaemia. These patients often require transfusions and more than 30% will discontinue treatment due to anaemia.
Patients who are transfusion-dependent have a poor prognosis and shortened survival.
“With momelotinib we have the potential to establish a new standard of care for myelofibrosis patients with anaemia,” said Ruben A. Mesa, President and Executive Director, of Atrium Health Levine Cancer Center.
“Addressing key manifestations of myelofibrosis, including anaemia, constitutional symptoms and splenomegaly, makes a significant difference in the treatment regimen for these patients who have limited options to address these aspects of the disease.”
