Lumoxiti
Drug - Lumoxiti™ (moxetumomab paudotox-tdfk) [AstraZeneca Pharmaceuticals LP]
September 2019
Therapeutic area - Oncology
Approval criteria
- Patient is at least 18 years or older AND
- Patient has a confirmed diagnosis of Hairy Cell Leukemia (HCL) AND
- Patient has relapsed or refractory disease AND
- Patient is pseudomonas-immunotoxin naïve (e.g., moxetumomab pasudotox) AND
- Patient does not have severe renal impairment (estimated creatinine clearance, ≤ 29 mL/min) AND
- Patient has previously failed ≥ 2 prior systemic therapies, of which included ≥ 1 of the following:
- Failure of 2 courses of purine analog therapy (e.g., cladribine, pentostatin) OR
- Failure to ≥ 1 purine analog therapy AND 1 course of rituximab or a BRAF-inhibitor (e.g., vemurafenib) AND
- Encorafenib will be used as initial therapy or subsequent therapy
- Approval will be for 6 months and not renewable
Quantity limits
- 1 mg single-dose vial: up to 14 vials per 28 days (dosed as 0.04 mg/kg days 1, 3, and 5 on 28-day cycles)
- Patient’s weight (in kg) must be submitted at time of request
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411