Johnson & Johnson Announces Health Canada Authorizes CARVYKTI For Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received 1-3 Prior Lines Of Therapy, Including A Proteasome Inhibitor And An Immunomodulatory Agent, And Who Are...
Johnson & Johnson Announces Health Canada Authorizes CARVYKTI For Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received 1-3 Prior Lines Of Therapy, Including A Proteasome Inhibitor And An Immunomodulatory Agent, And Who Are...
Canada's Drug Agency (CDA-AMC) has recently recommended CARVYKTI for reimbursement with conditions for eligible patients who have received one to three prior lines of therapy. In its rationale for the recommendation, CDA-AMC pointed out that the CARTITUDE-4 trial demonstrated that treatment with CARVYKTI, compared to standard of care, was associated with statistically significant and clinically meaningful improvements in progression-free survival (PFS) in eligible patients. This builds on their prior recommendation for reimbursement with conditions for CARVYKTI in 2023 in eligible patients who have received at least three prior lines of therapy, based on the results of the CARTITUDE-1 trial. Johnson & Johnson is actively working with the pan-Canadian Pharmaceutical Alliance to negotiate reimbursement for CARVYKTI to enable public access.Johnson & Johnson Announces Health Canada Authorizes CARVYKTI For Patients With Relapsed Or Refractory Multiple Myeloma Who Have Received 1-3 Prior Lines Of Therapy, Including A Proteasome Inhibitor And An Immunomodulatory Agent, And Who Are Refractory To Lenalidomide
强生公司宣布，加拿大卫生部已授权CARVYKTI用于接受过1-3个治疗方案的复发性或难治性多发性骨髓瘤患者治疗，这些患者包括使用过蛋白酶体抑制剂和免疫调节剂，并且对来那度胺耐药。
Authorization is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with CARVYKTI reduced the risk of disease progression or death by 74 per cent compared to standard of care.1
授权是基于三期CARTITUDE-4（MMY3002）研究的结果，该研究显示，与标准治疗相比，CARVYKTI的治疗减少了74%的疾病进展或死亡风险。
TORONTO, Nov. 21, 2024 /CNW/ - Johnson & Johnson (NYSE:JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with multiple myeloma who have received one to three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.1 With this approval, CARVYKTI becomes the first and only B-cell Maturation Antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as second line.
多伦多，2024年11月21日 /CNW/ - 强生公司（纽交所：JNJ）今天宣布，加拿大卫生部已为CARVYKTI（ciltacabtagene autoleucel）发布了合规通知（NOC），用于治疗接受过1到3个治疗方案的成人多发性骨髓瘤患者，包括蛋白酶体抑制剂和免疫调节剂，并且对来那度胺耐药。随着这一批准，CARVYKTI成为首个针对多发性骨髓瘤患者的b细胞成熟抗原（BCMA）靶向治疗，甚至可以在第二线时使用。
CARVYKTI previously received a Notice of Compliance with conditions (NOC/c) from Health Canada for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and who are refractory to their last treatment.1
CARVYKTI此前获得了加拿大卫生部的有条件合规通知（NOC/c），用于治疗接受过至少三条治疗方案的成人多发性骨髓瘤患者，包括蛋白酶体抑制剂、免疫调节剂和抗CD38抗体，并且对最后一次治疗耐药。
Canada's Drug Agency (CDA-AMC) has recently recommended CARVYKTI for reimbursement with conditions for eligible patients who have received one to three prior lines of therapy. In its rationale for the recommendation, CDA-AMC pointed out that the CARTITUDE-4 trial demonstrated that treatment with CARVYKTI, compared to standard of care, was associated with statistically significant and clinically meaningful improvements in progression-free survival (PFS) in eligible patients. This builds on their prior recommendation for reimbursement with conditions for CARVYKTI in 2023 in eligible patients who have received at least three prior lines of therapy, based on the results of the CARTITUDE-1 trial. Johnson & Johnson is actively working with the pan-Canadian Pharmaceutical Alliance to negotiate reimbursement for CARVYKTI to enable public access.
加拿大药物局（CDA-AMC）最近已建议对接受过1到3个治疗方案的合格患者有条件地报销CARVYKTI。在其建议的理由中，CDA-AMC指出，CARTITUDE-4试验表明，与标准治疗相比，接受CARVYKTI治疗的合格患者在无进展生存期（PFS）方面有统计学显著且临床意义重大的改善。这建立在他们2023年对至少接受过三条治疗方案的合格患者的CARVYKTI有条件报销的先前建议的基础上，这一建议是基于CARTITUDE-1试验的结果。强生公司正在积极与泛加药品联盟合作，以谈判CARVYKTI的报销，以确保公众的使用。
译文内容由第三方软件翻译。
