索托拉西布片 | China Drugs ListSotorasib tablets | China Drugs List
本页为公开参考信息，不构成医疗建议、处方或药品供应要约。请向持证专业人士确认当前批准情况、可获得性及适用性。
其他
- 商品名
- Lumakras
- 企业
- Amgen Inc.
- 药品类型
- 化学药Chemical medicine
- 治疗领域
- 肿瘤科Oncology
- 公开来源记录的适应症
- 美国：单药用于至少一种全身治疗后的成人KRAS G12C突变局部晚期或转移性非小细胞肺癌。与帕尼单抗联合，用于氟嘧啶类、奥沙利铂及伊立替康化疗后的成人KRAS G12C突变转移性结直肠癌。突变须通过FDA批准的检测方法确认；肺癌适应症为加速批准。US: Alone for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer after at least one systemic therapy. With panitumumab for adults with KRAS G12C-mutated metastatic colorectal cancer after fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Mutation must be confirmed by an FDA-approved test; the lung-cancer indication uses accelerated approval.
- 适应症来源与口径
- 美国处方资料 修订于 2025年1月. 部分境外适应症；不确立中国批准范围。US prescribing information revised January 2025. Selected overseas indications; does not establish the Chinese approved scope.
- 说明书信息局限
- 已链接境外官方处方资料；尚未核实完整的现行中国说明书。Overseas official prescribing information linked; a complete current Chinese label has not been verified.
- 中国可获得性状态
- 本次导入未独立核实中国批准、当地批准适应症及当前供应情况。Chinese approval, locally approved indications and current availability have not been independently verified in this import.
- 海外状态
- 请参阅所链接的境外监管机构或厂商证据。批准及适应症因司法辖区而异；尚未确认当前供应情况。See the linked overseas regulator / manufacturer evidence. Approval and indications are jurisdiction-specific; current supply is not established.
- 医保分类
- 尚未核实Not yet verified
- 医保版本
- 中国国家医保信息待核实Chinese national insurance review pending
- 医保核查说明
- 本次新增记录尚未确定报销资格；缺少信息不代表未被纳入。No reimbursement determination was made for this addition; missing information is not proof of exclusion.
来源
- https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c80a362c-7ac3-4894-a076-0691e68ef8c1&type=display
- Lumakras——官方处方资料Lumakras — official prescribing information
Official prescribing information · US prescribing information revised January 2025
已核查英文一手来源。此证据描述所引用的境外司法辖区情况，不能核实中国批准、适应症、报销或在售情况。English primary source reviewed. This evidence describes the cited overseas jurisdiction and does not verify Chinese approval, indications, reimbursement or market availability.
证据核查日期：