Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p19
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 19/161)
Character Range: 13938733–13946463

600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
                                                                                   A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347 472-80.)
C13134              P13134         CN13134          Brentuximab vedotin            CD30 positive peripheral T-cell lymphoma, non-cutaneous type                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND
                                                                                   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 cyclophosphamide, doxorubicin and prednisone; AND
                                                                                   The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.
                                                                                   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/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and
                                                                                   (b) The date of initial diagnosis of Peripheral T-cell lymphoma.
                                                                                   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) A completed authority prescription form; 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).
C13152              P13152         CN13152          Sunitinib                      Metastatic or unresectable malignant gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must not be resectable; AND
                                                                                   The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                   Patient must have a WHO performance status of 2 or less; AND
                                                                                   Patient must have previously failed or be intolerant to imatinib mesilate.
                                                                                   Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (a) A completed authority prescription form; and
                                                                                   (b) 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).
                                                                                   Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib.
C13153              P13153         CN13153          Sunitinib                      Metastatic or unresectable malignant gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures -