Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Acute lymphoblastic leukaemia

Induction treatment

The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND

Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND

Patient must not have received more than 1 line of salvage therapy; AND

Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND

The condition must be CD22-positive; AND

The condition must have more than 5% blasts in bone marrow; AND

The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.

This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

The authority application must be made in writing and must include:

(1) details of the proposed prescription(s);

(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and

(3) evidence that the condition is CD22-positive; and

(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and

(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.

The treatment must not exceed 0.8mg per m² for the first dose of a treatment cycle (Day 1), and 0.5mg per m² for subsequent doses (Days 8 and 15) within a treatment cycle.

Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.