Glofitamab (Columvi)

Cadth
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Abstract

CADTH recommends that Columvi be reimbursed by public drug plans for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received 2 or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy if certain conditions are met. Columvi should only be covered to treat adult patients who have DLBCL not otherwise specified, trFL, or PMBCL that has come back or that did not respond to 2 or more previous treatments for their cancer, and who have also previously received CAR-T cell therapy, declined CAR-T cell therapy, or cannot receive CAR-T cell therapy. Columvi should only be reimbursed for a maximum of 12 treatment cycles, after a single dose of obinutuzumab to reduce the risk of cytokine release syndrome (CRS) and should not be given in combination with other anticancer drugs. Reimbursement of Columvi should be discontinued if a patient’s cancer grows or spreads or if treatment is unacceptably toxic to the patient. Columvi should only be reimbursed when prescribed by specialists with experience managing DLBCL, and if its cost is reduced.
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格洛菲坦单抗(Columvi)
CADTH 建议,Columvi 用于治疗复发或难治性 (R/R) 非特异性弥漫大 B 细胞淋巴瘤 (DLBCL)、由滤泡性淋巴瘤 (trFL) 引发的 DLBCL 或原发性纵隔 B 细胞淋巴瘤 (PMBCL) 的成人患者,这些患者已接受过 2 种或 2 种以上的系统治疗,且不符合或无法接受 CAR-T 细胞疗法,或在满足特定条件的情况下曾接受过 CAR-T 细胞疗法。Columvi仅适用于治疗以下成年患者:未另作规定的DLBCL、TrFL或复发的PMBCL,或对之前的2种或2种以上癌症治疗无效,且之前也接受过CAR-T细胞治疗、拒绝接受CAR-T细胞治疗或不能接受CAR-T细胞治疗的患者。为降低细胞因子释放综合征(CRS)的风险,Columvi 最多只能报销 12 个治疗周期,且必须在单剂量奥比妥珠单抗治疗后进行,并且不得与其他抗癌药物联合使用。如果患者的癌症生长或扩散,或治疗对患者产生不可接受的毒性,则应停止对 Columvi 的报销。Columvi 只有在由具有管理 DLBCL 经验的专科医生开具处方并降低费用的情况下才能报销。
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