FDA Approves Bristol Myers Squibb's Combination Therapy For Colorectal Cancer Patients With Certain Type Of Gene Mutation
FDA Approves Bristol Myers Squibb's Combination Therapy For Colorectal Cancer Patients With Certain Type Of Gene Mutation
Friday, the FDA granted accelerated approval to Bristol Myers Squibb & Co's (NYSE:BMY) Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC), who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
FDA于星期五批准了百时美施贵宝（NYSE:BMY）的Krazati （adagrasib）与曲妥昔单抗联合使用，作为成人局部晚期转移性结直肠癌（CRC）KRAS G12C 突变患者的靶向治疗选择。（adagrasib）与曲妥昔单抗联合使用是治疗成人局部晚期或转移性结直肠癌（CRC）KRASG12C突变患者的靶向治疗期权。该指示是基于ORR和DOR结果的快速批准，ORR为34％，全部为部分响应。先前接受过氟嘧啶，奥沙利铂和伊立替康为基础的化疗的局部晚期或转移性结直肠癌（CRC）KRASG12C突变患者，可以接受adagrasib与曲妥昔单抗联合使用的治疗。
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results.
该指示基于ORR和DOR结果的快速批准。
Bristol Myers Squibb added adagrasib via its $5 billion Mirati Therapeutics Inc. deal.
百时美施贵宝通过其以50亿美元收购Mirati Therapeutics公司的交易增加了adagrasib的业务范围。
The approval is based on results from cohorts of the Phase 1/2 KRYSTAL-1 open-label study, which evaluated Krazati (600 mg tablets administered orally twice daily) in combination with cetuximab in 94 patients with heavily pretreated CRC harboring a KRASG12C mutation.
批准是基于1/2期KRYSTAL-1开放标签研究的结果，该研究评估了在94名重度预处理的KRASG12C结直肠癌患者中以曲妥昔单抗联合使用Krazati（600mg 口服两次/天）的有效性。KRAS G12C是一种突变。该研究的目标确立是降低在累积化疗或通过靶向治疗之前进展后被诊断为局部晚期或转移性结直肠癌（CRC）的KRAS G12C阳性患者中疾病控制率的最佳水平。
The study met its primary endpoint, with a confirmed ORR of 34% for Krazati with cetuximab, all of which were partial responses.
该研究达到了其主要终点，Krazati与曲妥昔单抗的确认ORR为34％，所有都是部分响应。
The median DOR, one of the secondary endpoints, was 5.8 months.
中位持续时间反应（DOR）为5.8个月。
Current late-line standard of care options results in limited response rates (ORR 1-6%) after progression on chemotherapy ± VEGF/VEGFR inhibitors.
目前晚期标准的治疗期权的结果是化疗+ VEGF / VEGFR抑制剂之后的有限响应率（ORR1-6％）。
The company partnered with QIAGEN NV (NYSE:QGEN) to develop a tissue-based companion diagnostic (CDx) for Krazati that is now available.
该公司与QIAGEN NV（NYSE：QGEN）合作开发了一种组织为基础的伴随诊断（CDx），用于验证Krazati，现已上市。
The company added that Krazati is associated with the following Warnings & Precautions: Gastrointestinal adverse reactions including diarrhea, nausea, and vomiting, QTc interval prolongation, hepatotoxicity, and interstitial lung disease (ILD)/pneumonitis.
该公司补充说，Krazati与以下警告和注意事项有关：胃肠道不良反应，包括腹泻，恶心和呕吐，QTc间期延长，肝毒性和间质性肺疾病（ILD）/肺炎。
In 2022, Krazati was granted accelerated approval for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer, who have received at least one prior systemic therapy.
2022年，Krazati获得了快速批准，适用于KRAS G12C突变的局部晚期或转移性非小细胞肺癌患者，这些患者已接受至少一种系统性治疗。KRAS G12C是一种突变。路透社援引晨星分析师的话指出，"批准有助于证明百时美施贵宝收购Mirati公司的决定是正确的。" 分析师估计，Krazati的年销售额仅逾十亿美元。
Reuters, citing a Morning Star analyst, notes that "The approval helps justify Bristol's decision to buy Mirati." The analyst estimates just over a billion dollars in annual sales for Krazati.
BMY股票在周一盘前最后报价涨0.38％，报42.09美元。
Price Action: BMY shares are up 0.38% at $42.09 during the premarket session at last check Monday.
价格行动: BMY股票在周一盘前交易时段最后检查报价为42.09美元，上涨0.38%。
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图片来自shutterstock。