Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p23
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 23/69)
Character Range: 353526–362239

another cause;
                                                                                                                d) Extramedullary leukaemia.
C12656              P12656         Sacituzumab govitecan                                                        Unresectable locally advanced or metastatic triple‑negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 12656
                                                                                                                Initial treatment
                                                                                                                Patient must have progressive disease following two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting; AND
                                                                                                                The condition must be inoperable; AND
                                                                                                                Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this PBS indication.
C12669              P12669         Sacituzumab govitecan                                                        Unresectable locally advanced or metastatic triple‑negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 12669
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this PBS indication.
C12691              P12691         Daratumumab                                                                  Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                Continuing treatment of second‑line drug therapy from week 25 until disease progression (administered every 4 weeks)
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have developed disease progression while receiving treatment with this drug for this condition.
                                                                                                                Progressive disease is defined as at least 1 of the following:
                                                                                                                (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                (b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
                                                                                                                (c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
                                                                                                                (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
                                                                                                                (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
                                                                                                                (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
                                                                                                                (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
                                                                                                                Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
C12694              P12694         Carfilzomib                                                                  Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 12694
                                                                                                                Initial treatment ‑ once weekly treatment regimen
                                                                                                                The condition must be confirmed