Elzonris™

Drug - Elzonris™ (tagraxofus injection) [Stemline Therapeutics Inc.]

July 2019

Therapeutic area - Hematology/Oncology

Approval criteria

Patient must be ≥ 2 years of age AND
Patient must have a definitive diagnosis of BPDCN in the peripheral blood, bone marrow, spleen, lymph nodes, skin, and/or other sites AND
Patient has CD-123 positive/expressing disease AND
Patient has a baseline serum albumin level ≥ 3.2 g/dL AND
Patient does not have significant cardiovascular disease (e.g., uncontrolled or any NYHA Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of therapy initiation, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication, baseline left ventricular ejection fraction ≤ 40%) AND
If a female patient of reproductive potential, confirmation that patient is not pregnant (as documented with a negative pregnancy test within 7 days of therapy initiation)
Initial approval is for 6 months

Patient continues to meet the initial criteria AND
Absence of unacceptable toxicity from the drug. Examples include any of the following: capillary leak syndrome (e.g., hypoalbuminemia, edema/weight gain, pulmonary edema, hypotension, etc.), severe hypersensitivity, severe hepatotoxicity (e.g., AST/ALT > 5 times the ULN), nephrotoxicity (e.g., serum creatinine > 1.8 mg/dL or creatinine clearance ≤ 60 mL/minute), cardiovascular effects (e.g., systolic blood pressure ≥ 160 mmHg or ≤ 80 mmHg; or heart rate ≥ 130 bpm or ≤ 40 bpm), etc. AND
Disease stabilization or improvement as evidenced by a complete response [CR] (e.g., morphologic, cytogenetic or molecular complete response CR) or clinical complete response [CRc] (e.g., complete response with residual skin abnormality not indicative of active disease)
Renewal approval is for 6 months

MHCP Provider Call Center 651-431-2700 or 800-366-5411