Merck's Keytruda Secures First FDA-Approval For Rare Form Aggressive Cancer
Merck's Keytruda Secures First FDA-Approval For Rare Form Aggressive Cancer
MPM is a rare, aggressive cancer that forms in the lining of the lungs and chest.Wednesday, the FDA approved Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
週三，FDA批准了默沙東公司（NYSE:MRK）的凱特魯達（帕姆單抗）與培美曲塞和鉑類化療聯合用於成年患者不可割除的晚期或轉移性惡性胸膜間皮瘤（MPM）的一線治療。
The approval marks the first indication for Keytruda in MPM in the U.S.
該批准標誌着Keytruda在美國MPM中的首個適應症。
Also Read: Merck/Daiichi Sankyo Partnered Lung Cancer Candidate Meets Primary Goal In Late-Stage Study.
此外，還有:默沙東/第一三共合作的肺癌候選藥在晚期研究中達到了主要目標。
MPM is a rare, aggressive cancer that forms in the lining of the lungs and chest.
MPM是一種罕見而侵襲性的癌症，起源於肺部和胸腔的內膜。
The approval is based on pivotal Phase 2/3 IND.227/KEYNOTE-483 trial data.
該批准基於重要的2/3期IND.227/KEYNOTE-483試驗數據。
Keytruda plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% compared to chemotherapy alone.
與單獨化療相比，凱特魯達加化療組在總生存期（OS）上有顯著改善，死亡風險降低了21%。
Median OS was 17.3 months for Keytruda plus chemotherapy versus 16.1 months for chemotherapy alone.
凱特魯達加化療組的中位OS爲17.3個月，而僅化療組爲16.1個月。
Keytruda plus chemotherapy also significantly improved progression-free survival (PFS) versus chemotherapy alone.
凱特魯達加化療組還顯著改善了無進展生存期（PFS），相比僅化療組。
The overall response rate (ORR) was significantly higher for Keytruda plus chemotherapy versus chemotherapy alone (52% versus 29%), respectively.
Keytruda與化療相比，總體反應速率(ORR)顯著較高(52%對29%)。
Adverse reactions occurring in patients with MPM were generally similar to those in other patients receiving Keytruda in combination with pemetrexed and platinum chemotherapy.
患有MPm的患者的不良反應與其他接受Keytruda聯合培美曲塞和鉑類化療的患者基本相似。
In August, Merck discontinued two Keytruda late-stage studies.
默沙東在八月份停止了兩個Keytruda的後期研究。
- Phase 3 KEYNOTE-867 trial evaluating Keytruda (pembrolizumab) in combination with stereotactic body radiotherapy for stage I or II non-small cell lung cancer, including those who are medically inoperable or have refused surgery.
- Phase 3 KEYNOTE-630 trial of Keytruda for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation, based on the recommendation of an independent DMC.
- Phase 3 KEYNOTE-867試驗評估Keytruda (pembrolizumab)與立體定向體放射治療聯合應用於I或II期非小細胞肺癌患者，包括那些在醫學上不能手術或拒絕手術的患者。
- Phase 3 KEYNOTE-630試驗根據獨立DMC的建議，評估Keytruda作爲高風險局部晚期鱗狀細胞癌(cSCC)患者手術和放療後的輔助治療。
Price Action: MRK stock is trading 0.04% higher at $118.34 at the last check on Wednesday.
MRk股票在上週三的最後一次查詢中交易價格爲118.34美元，較之前上漲了0.04%。
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譯文內容由第三人軟體翻譯。