Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice
Serious adverse reactions occurred in 52% of patients who received MONJUVI
Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%)
Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%), and sudden death (1.2%)
Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%
The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%)
Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%
The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%)
|Adverse Reaction||All Grades
|Grade 3 or 4
|Blood and lymphatic system disorders|
|General disorders and administration site conditions|
|Respiratory, thoracic, and mediastinal disorders|
|Respiratory tract infection†||24||4.9|
|Urinary tract infection‡||17||4.9|
|Metabolism and nutrition disorders|
|Musculoskeletal and connective tissue disorders|
*Fatigue includes asthenia and fatigue.
†Respiratory tract infection includes: lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection.
‡Urinary tract infection includes: urinary tract infection, Escherichia urinary tract infection, urinary tract infection bacterial, urinary tract infection enterococcal.
Clinically relevant adverse reactions in <10% of patients in L-MIND were:
Blood and lymphatic system disorders: lymphopenia (6%)
General disorders and administration site conditions: IRR (6%)
Infections: sepsis (4.9%)
Investigations: weight decreased (4.9%)
Musculoskeletal and connective tissue disorders: arthralgia (9%), pain in extremity (9%), musculoskeletal pain (2.5%)
Neoplasms benign, malignant, and unspecified: basal cell carcinoma (1.2%)
Nervous system disorders: headache (9%), paresthesia (7%), dysgeusia (6%)
Respiratory, thoracic, and mediastinal disorders: nasal congestion (4.9%), exacerbation of chronic obstructive pulmonary disease (1.2%)
Skin and subcutaneous tissue disorders: erythema (4.9%), alopecia (2.5%), hyperhidrosis (2.5%)
|Laboratory Abnormality||All Grades
|Grade 3 or 4
|Gamma glutamyl transferase increased||34||5|
|Aspartate aminotransferase increased||20||0|
|Activated partial thromboplastin time increased||46||4.1|
§The denominator used to calculate the rate was 74 based on the number of patients with a baseline value and at least one post-treatment value.
As with all therapeutic proteins, there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assays. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described in the Prescribing Information with the incidence of antibodies in other studies or to other tafasitamab products may be misleading.
Overall, no treatment-emergent or treatment-boosted anti-tafasitamab antibodies were observed. No clinically meaningful differences in the pharmacokinetics, efficacy, or safety profile of tafasitamab-cxix were observed in 2.5% of 81 patients with relapsed or refractory DLBCL with pre-existing anti-tafasitamab antibodies in L-MIND.