Loading
If this is the first time anyone has visited this substance, we may be fetching live data from TGA Product Information, PBS, and state framework sources — that can take up to a minute. Cached substances load in a second or two.
Brentuximab vedotin, sold under the brand name Adcetris, is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL. The drug is being jointly marketed by Millennium Pharmaceuticals outside the US and by Seagen in the US.
Read the full article on WikipediaCD30 positive systemic anaplastic large cell lymphoma Clinical criteria: Treatment Phase: Initial treatment The treatment must be for curative intent, AND Patient must have undergone appropriate prior front-line curative intent chemotherapy, AND Patient must demonstrate relapsed or chemotherapy-refractory disease, AND Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type, AND The treatment must not exceed 4 cycles under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and (b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and (c) Dates of commencement and completion of front-line curative intent chemotherapy; and (d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; and (ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Relapsed or Refractory Hodgkin lymphoma Clinical criteria: Treatment Phase: Continuing treatment Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition, AND Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition, AND Patient must not receive more than 12 cycles of treatment under this restriction. The treatment must not exceed a total of 16 cycles for this condition in a lifetime.
CD30 positive cutaneous T-cell lymphoma Clinical criteria: Treatment Phase: Initial treatment Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma, AND Patient must have CD30 positivity of at least 3% of malignant cells, AND Patient must have a diagnosis of mycosis fungoides; OR Patient must have a diagnosis of Sezary syndrome; OR Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma, AND Patient must have received prior systemic treatment for this condition, AND The condition must be relapsed or refractory, AND The treatment must not exceed 4 cycles under this restriction in a lifetime, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and (b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and (c) Date of commencement and completion of the most recent prior systemic treatment. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; and (ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
CD30 positive peripheral T-cell lymphoma, non-cutaneous type Clinical criteria: Treatment Phase: 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.
Stage III or IV CD30 positive Hodgkin lymphoma Clinical criteria: The treatment must be for first line therapy for this condition, AND The treatment must be for curative intent, AND The treatment must be in combination with at least the following: (i) doxorubicin, (ii) vinblastine, AND The treatment must not be in combination with (i) etoposide, (ii) cyclophosphamide, AND The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.
Working under the parallel aged-care framework? Aged-care equivalent →