On June 18, the U.S. Food and Drug Administration approved tafasitamab-cxix (Monjuvi), a CD19-directed cytolytic antibody, with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
inMIND Trial
Efficacy was evaluated in inMIND (ClinicalTrials.gov identifier NCT04680052), a double-blind, placebo-controlled trial. Investigators randomly assigned 548 patients with relapsed or refractory follicular lymphoma to receive tafasitamab or placebo with lenalidomide and rituximab. Patients had received a median of one prior line of systemic therapy; 25% and 20% had received two and three or more prior lines, respectively.
The major efficacy outcome measure was investigator-assessed progression-free survival. After a median follow-up of 14.1 months, progression-free survival was statistically significantly longer in the tafasitamab (hazard ratio = 0.43, 95% confidence interval [CI] = 0.32–0.58, P < .0001). The estimated median progression-free survival was 22.4 months (95% CI = 19.2 months to not evaluable) in the tafasitamab arm and 13.9 months (95% CI = 11.5–16.4 months) in the control arm.
Serious adverse reactions occurred in 33% of patients in the tafasitamab arm, including serious infections in 24%. The prescribing information for tafasitamab includes warnings and precautions for infusion-related reactions, myelosuppression, and infections.
Recommended Dosage
The recommended tafasitamab dose is 12 mg/kg as an intravenous infusion for a maximum of 12 cycles with lenalidomide and rituximab. Tafasitamab is neither indicated nor recommended for patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
Expedited Programs
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence which provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Australian Therapeutic Goods Administration and Health Canada. The application reviews are ongoing at the other regulatory agencies.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted Priority Review. Tafasitamab received Orphan Drug designation for follicular lymphoma.
