Tafasitamab-cxix (Monjuvi®) received accelerated approval from the U.S. Food and Drug Administration in July 2020 in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Humanized Fc-modified cytolytic CD19-targeting monoclonal antibody
Patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant
Administer 12 mg/kg in combination with lenalidomide 25 mg for a maximum of twelve 28-day cycles. Tafasitamab-cxix may be continued as monotherapy until patients experience disease progression or severe toxicity.
Premedicate at least 30 minutes prior to tafasitamab-cxix infusion with acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and glucocorticoids. Tafasitamab-cxix is administered as an IV infusion. The first dose should be infused at a rate of 70 ml per hour for the first 30 minutes, then increase the rate to infuse the remainder within 1.5–2.5 hours. Subsequent infusions do not need titration and can be administered over 1.5–2 hours.
More than 20% of patients experienced neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. The tafasitamab-cxix package insert carries the following warnings and precautions: possible severe reactions include infusion-
related reactions (chills, flushing, dyspnea, and hypertension), myelosuppression, infection, and embryo-fetal toxicity.
Both tafasitamab-cxix and lenalidomide can result in major birth defects and miscarriage; verify pregnancy status prior to initiating therapy and educate patients about using effective contraception. Myelosuppression can occur; assess complete blood counts prior to and throughout treatment.
Drug-Drug and Drug-Food Interactions
No interactions are noted in the package insert.
Patients of reproductive potential should use effective contraception during and for three months following treatment. Breastfeeding during and for three months following treatment is not advised.
Data were insufficient to support differences in efficacy between younger patients and those aged 65 years or older. However, clinical studies did demonstrate increased risk for serious adverse reactions in patients aged 65 or older (57%) compared to younger patients (39%).
Based on its mechanism of action, tafasitamab-cxix can cause fetal harm.
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