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

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

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