adult patients with previously untreated mantle cell lymphoma (MCL). Routes of administration: Intravenously (IV) or subcutaneously (SC) Dosage: The recommended dosage for bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) for the treatment of patients with previously untreated Mantle Cell Lymphoma is 1.3 mg/m2 body surface area twice weekly for 2 weeks on days 1, 4, 8, and 11 followed by a 10 day rest period on days 12-21. This 3 week cycle is considered a treatment cycle. ARTG number: 238257 Product background This AusPAR describes the application by Janssen-Cilag Pty Ltd to extend the indication for Velcade (trade name; active ingredient, bortezomib). Bortezomib is currently registered for the treatment of multiple myeloma. The proposed indication is for combination treatment with bortezomib and rituximab, cyclophosphamide, doxorubicin and prednisone in adults with previously untreated mantle cell lymphoma (MCL). The proposed dosing regimen for MCL is 1.3 mg/m2 IV bortezomib twice weekly for two weeks (on days 1, 4, 8 and 11, h between doses), followed by a 10 day rest period ≥72 (days 12-21). This 3 week cycle is repeated for 6 cycles, with an optional additional 2 cycles. This dosing regimen is the same as that approved for multiple myeloma indications. Details of the dosing regimen for the combination are provided in the Product Information (PI). Regulatory status The international regulatory status for frontline MCL at the time of this submission is listed in Table 1. Table 1: International regulatory status. Country Date Approval Approved indication submitted date or intend to submit EU* 12 Jun 2014 30 Jan 2015 Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation
adult patients with previously untreated mantle cell lymphoma (MCL). Routes of administration: Intravenously (IV) or subcutaneously (SC) Dosage: The recommended dosage for bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) for the treatment of patients with previously untreated Mantle Cell Lymphoma is 1.3 mg/m2 body surface area twice weekly for 2 weeks on days 1, 4, 8, and 11 followed by a 10 day rest period on days 12-21. This 3 week cycle is considered a treatment cycle. ARTG number: 238257 Product background This AusPAR describes the application by Janssen-Cilag Pty Ltd to extend the indication for Velcade (trade name; active ingredient, bortezomib). Bortezomib is currently registered for the treatment of multiple myeloma. The proposed indication is for combination treatment with bortezomib and rituximab, cyclophosphamide, doxorubicin and prednisone in adults with previously untreated mantle cell lymphoma (MCL). The proposed dosing regimen for MCL is 1.3 mg/m2 IV bortezomib twice weekly for two weeks (on days 1, 4, 8 and 11, ≥72 h between doses), followed by a 10 day rest period (days 12-21). This 3 week cycle is repeated for 6 cycles, with an optional additional 2 cycles. This dosing regimen is the same as that approved for multiple myeloma indications. Details of the dosing regimen for the combination are provided in the Product Information (PI). Regulatory status The international regulatory status for frontline MCL at the time of this submission is listed in Table 1. Table 1: International regulatory status. Country Date submitted or intend to submit Approval date Approved indication EU* 12 Jun 2014 30 Jan 2015 Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation
auspar-bortezomib-160226.docx