FDA Approves Momelotinib (Ojjaara) for Myelofibrosis Patients with Anemia
Benefits and Considerations: Navigating Momelotinib’s Usage with Dr. Mascarenhas
In a significant development, the US Food and Drug Administration (FDA) has granted approval to OJJAARA (momelotinib) for the treatment of intermediate or high-risk myelofibrosis (This includes cases of primary myelofibrosis and secondary myelofibrosis occurring after polycythemia vera and essential thrombocythemia) in adults with anemia, according to a media release by GSK.
Myelofibrosis, a rare blood cancer affecting approximately 25,000 patients in the US, often leads to severe complications such as anemia, constitutional symptoms, and splenomegaly. About 40% of patients already have moderate to severe anemia at the time of diagnosis, and nearly all patients are estimated to develop anemia during the course of their disease, as reported by the American Cancer Society.
With the FDA approval of momelotinib, myelofibrosis patients likely have questions about its usage and possible benefits of the drug.
Dr. John Mascarenhas (Mount Sinai), an expert in myelofibrosis treatment, highlights the unique features of momelotinib: “Momelotinib is a JAK inhibitor so it’s much like ruxolitinib (Jakafi) except there are some nuances that make these drugs a little bit different,” he says. “It also inhibits ACVR1, which is another pathway that regulates iron availability for red blood cell production.”
The journey of momelotinib to FDA approval involved the MOMENTUM study. While initially expected to be approved in late June, it faced a delay for re-review by the FDA, as reported by GSK.
Regarding potential benefits and considerations in momelotinib’s use, Dr. Mascarenhas explains, “Momelotinib is a JAK inhibitor so it’s much like ruxolitinib (Jakafi) except as I mentioned before, there are some nuances that make these drugs a little bit different. It also inhibits ACVR1, which is another pathway that regulates iron availability for red blood cell production. In its long development history, it’s differentiated itself from other drugs in large part by its ability to improve hemoglobins in a subset of patients.”
In terms of treatment, Dr. Mascarenhas emphasizes the importance of personalized care: “I encourage patients to discuss with their physicians if that drug might make sense for them or any of the other drugs that we’ve talked about, whether it’s fedratinib, ruxolitinib, or pacritinib. As we’ve said, it really has to be tailored to the patient.”
In conclusion, the FDA’s approval of momelotinib marks a significant step forward in addressing the challenges faced by myelofibrosis patients, especially those with anemia. Dr. Mascarenhas’s insights provide a deeper understanding of the drug’s unique attributes and its potential to benefit those affected by this blood cancer.
The Latest Myelofibrosis Clinical Trials
If you’re interested in learning more about the latest myelofibrosis clinical trials, explore our conversation with Myelofibrosis experts Dr. Mascarenhas and Dr. Tania Jain (Johns Hopkins Medicine), and Clinical Trial Nurse Ashley Giacobbi (The Leukemia & Lymphoma Society) as they explain cutting-edge therapies.
But there are an unprecedented number of clinical trials that, again, if a patient is out there and has myelofibrosis and things are not doing well, or their spleen is too large, or they’re not feeling well, or they’re having side effects from medicines, one or more of these clinical trials may be an option for them.
Dr. Ruben Mesa |MF Clinical Trials
Myelofibrosis Patient Stories
Stacy S.
Diagnosis: Myelofibrosis with CALR and ASXL1 mutations
Symptoms: Fatique, cold hands and feet
Treatment: Agrylin (for thrombocythemia), Ruxolitinib (Jakafi), Fedratinib (INREBIC), stem cell transplant
Mary L.
Diagnosis: Myelofibrosis (MPN)
1st Symptoms: Fatigue, extreme dizziness (later diagnosed as vertigo)
Treatment: Pegasys, hydroxyurea (current)
