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Trastuzumab emtansine, sold under the brand name Kadcyla, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the cytotoxic agent DM1. Trastuzumab alone stops growth of cancer cells by binding to the HER2 receptor, whereas trastuzumab emtansine undergoes receptor-mediated internalization into cells, is catabolized in lysosomes where DM1-containing catabolites are released and subsequently bind tubulin to cause mitotic arrest and cell death. Trastuzumab binding to HER2 prevents homodimerization or heterodimerization (HER2/HER3) of the receptor, ultimately inhibiting the activation of MAPK and PI3K/AKT cellular signalling pathways. Because the monoclonal antibody targets HER2, and HER2 is only over-expressed in cancer cells, the conjugate delivers the cytotoxic agent DM1 specifically to tumor cells. The conjugate is abbreviated T-DM1.
Read the full article on WikipediaMetastatic (Stage IV) HER2 positive breast cancer Clinical criteria: Treatment Phase: Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority, AND The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab, AND Patient must have a WHO performance status of 0 or 1, AND The treatment must be the sole PBS-subsidised therapy for this condition, AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. The following information must be provided by the prescriber at the time of application: (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH). (b) dates of treatment with trastuzumab and pertuzumab; (c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or (d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. All reports must be documented in the patient's medical records. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
Early HER2 positive breast cancer Clinical criteria: Treatment Phase: Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery, AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report, AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery, AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure, AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for 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 the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery. The pathology report 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). Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
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