WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). This marks a significant milestone in providing a chemotherapy-free treatment option for this challenging and recurrent type of cancer.
The approval follows data from the Phase 3 inMIND trial, which demonstrated Monjuvi’s ability to improve progression-free survival (PFS). Patients receiving the Monjuvi combination achieved a median PFS of 22.4 months compared to 13.9 months for those in the control group. The study met its primary endpoint, showing a 57% reduction in the risk of disease progression or death.
“Patients living with relapsed or refractory FL have been waiting for new options that improve progression-free survival without substantial increase in side effects,” said Hervé Hoppenot, CEO of Incyte. “Today’s approval brings to this patient population the first CD-19 and CD20-targeted immunotherapy combination and a potential new treatment standard.”
Follicular lymphoma accounts for up to 30% of non-Hodgkin lymphoma (NHL) cases. Despite its slow progression, frequent relapses make long-term disease control a critical goal. Dr. Christina Poh, an Assistant Professor at the University of Washington and the Fred Hutchinson Cancer Center, highlighted the advancement. “The FDA approval of Monjuvi in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease,” she said.
Monjuvi’s safety profile was also evaluated, with common adverse reactions including respiratory infections, diarrhea, fatigue, and rash. Serious adverse effects were reported in 33% of patients, including infections and second primary malignancies, while fatal adverse events occurred in 1.5%.
Mitchell Smith, M.D., Ph.D., Chief Medical Officer of the Follicular Lymphoma Foundation, emphasized the importance of this new option, stating, “While the initial responses to FL treatment are often positive, recurrence can become increasingly difficult for patients to manage as they navigate emotions and the next treatment steps related to relapse. The FDA’s approval of this treatment combination offers a new option for patients living with this chronic disease.”
This approval builds on Monjuvi’s earlier authorization for diffuse large B-cell lymphoma (DLBCL). It provides hope for thousands of FL patients navigating the complexities of recurrent disease, offering a more effective and tolerable treatment option.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.