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

CD30 positive peripheral T-cell lymphoma, non-cutaneous type

Continuing treatment

The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND

Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND

Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND

The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.

Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as:

(a) Positron emission tomography-based response: lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR

(b) Computed tomography-based response: lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.