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於星期五批准了百時美施貴寶（NYSE:BMY）的Krazati （adagrasib）與曲妥昔單抗聯合使用，作爲成人局部晚期轉移性結直腸癌（CRC）KRAS G12C 突變患者的靶向治療選擇。（adagrasib）與曲妥昔單抗聯合使用是治療成人局部晚期或轉移性結直腸癌（CRC）KRASG12C突變患者的靶向治療期權。KRAS G12C是一種突變。先前接受過氟嘧啶，奧沙利鉑和伊立替康爲基礎的化療的局部晚期或轉移性結直腸癌（CRC）KRASG12C突變患者，可以接受adagrasib與曲妥昔單抗聯合使用的治療。
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results.
該指示基於ORR和DOR結果的快速批准。
Bristol Myers Squibb added adagrasib via its $5 billion Mirati Therapeutics Inc. deal.
百時美施貴寶通過其以50億美元收購Mirati Therapeutics公司的交易增加了adagrasib的業務範圍。
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.
批准是基於1/2期KRYSTAL-1開放標籤研究的結果，該研究評估了在94名重度預處理的KRASG12C結直腸癌患者中以曲妥昔單抗聯合使用Krazati（600mg 口服兩次/天）的有效性。KRAS G12C是一種突變。該研究的目標確立是降低在累積化療或通過靶向治療之前進展後被診斷爲局部晚期或轉移性結直腸癌（CRC）的KRAS G12C陽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.
該研究達到了其主要終點，Krazati與曲妥昔單抗的確認ORR爲34％，所有都是部分響應。
The median DOR, one of the secondary endpoints, was 5.8 months.
中位持續時間反應（DOR）爲5.8個月。
Current late-line standard of care options results in limited response rates (ORR 1-6%) after progression on chemotherapy ± VEGF/VEGFR inhibitors.
目前晚期標準的治療期權的結果是化療+ VEGF / VEGFR抑制劑之後的有限響應率（ORR1-6％）。
The company partnered with QIAGEN NV (NYSE:QGEN) to develop a tissue-based companion diagnostic (CDx) for Krazati that is now available.
該公司與QIAGEN NV（NYSE：QGEN）合作開發了一種組織爲基礎的伴隨診斷（CDx），用於驗證Krazati，現已上市。
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.
該公司補充說，Krazati與以下警告和注意事項有關：胃腸道不良反應，包括腹瀉，噁心和嘔吐，QTc間期延長，肝毒性和間質性肺疾病（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獲得了快速批准，適用於KRAS G12C突變的局部晚期或轉移性非小細胞肺癌患者，這些患者已接受至少一種系統性治療。KRAS G12C是一種突變。路透社援引晨星分析師的話指出，"批准有助於證明百時美施貴寶收購Mirati公司的決定是正確的。" 分析師估計，Krazati的年銷售額僅逾十億美元。
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股票在週一盤前最後報價漲0.38％，報42.09美元。
Price Action: BMY shares are up 0.38% at $42.09 during the premarket session at last check Monday.
價格行動: BMY股票在週一盤前交易時段最後檢查報價爲42.09美元，上漲0.38%。
Photo via Shutterstock
圖片來自shutterstock。
譯文內容由第三人軟體翻譯。