Efficacy in metastatic disease The sponsor is seeking approval for the new SC regimen in the treatment of metastatic disease. The population included in the pivotal study consisted of subjects with localised or locally advanced disease. Patients with metastatic disease were excluded. The study also compared the proposed SC regimen with the 6-mg/kg q3 weeks IV regimen. In Australia the only regimen approved for use in metastatic disease is the 2-mg/kg q1 week regimen (see Table 20). This was the dosage regimen used in the pivotal efficacy studies in this setting. An application for approval of the 6-mg/kg q3 weeks IV regimen in metastatic disease was not approved by the TGA. Table 20: Approved indications and approved and proposed dosage regimens. Shaded areas indicate changes that are the subject of the current application. Approved Indication RoA Loading Subsequent Duration dose doses Localised Breast Cancer IV 8 mg/kg 6 mg/kg every 1 year 3 weeks Treatment of HER2-positive localised breast cancer IV 4 mg/kg 2 mg/kg every 1 year following surgery, and in 1 week association with chemotherapy and, if SC - 600 mg every 1 year applicable, radiotherapy. 3 weeks Locally Advanced Breast IV 8 mg/kg 6 mg/kg every 1 year Cancer 3 weeks Treatment of HER2-positive SC - 600 mg every 1 year locally advanced breast 3 weeks cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN. IV 4 mg/kg 2 mg/kg every Until disease Metastatic Breast Cancer 1 week progression Treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: As monotherapy for the SC - 600 mg every Until disease treatment of those patients 3 weeks progression who have received one or more chemotherapy regimens for their metastatic disease; In combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or
Efficacy in metastatic disease The sponsor is seeking approval for the new SC regimen in the treatment of metastatic disease. The population included in the pivotal study consisted of subjects with localised or locally advanced disease. Patients with metastatic disease were excluded. The study also compared the proposed SC regimen with the 6-mg/kg q3 weeks IV regimen. In Australia the only regimen approved for use in metastatic disease is the 2-mg/kg q1 week regimen (see Table 20). This was the dosage regimen used in the pivotal efficacy studies in this setting. An application for approval of the 6-mg/kg q3 weeks IV regimen in metastatic disease was not approved by the TGA. Table 20: Approved indications and approved and proposed dosage regimens. Shaded areas indicate changes that are the subject of the current application. Approved Indication RoA Loading dose Subsequent doses Duration Localised Breast Cancer Treatment of HER2-positive localised breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy. IV 8 mg/kg 6 mg/kg every 3 weeks 1 year IV 4 mg/kg 2 mg/kg every 1 week 1 year SC - 600 mg every 3 weeks 1 year Locally Advanced Breast Cancer Treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN. IV 8 mg/kg 6 mg/kg every 3 weeks 1 year SC - 600 mg every 3 weeks 1 year Metastatic Breast Cancer Treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: As monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; In combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or IV 4 mg/kg 2 mg/kg every 1 week Until disease progression SC - 600 mg every 3 weeks Until disease progression
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