キイトルーダ、転移性非扁平上皮非小細胞肺がんの一次治療における3剤併用療法が欧州でも承認【米・Merck】

 米・Merck社は2018年9月10日、免疫チェックポイント阻害薬の抗PD-1抗体であるペムブロリズマブ(商品名キイトルーダ)について、未治療の転移性非扁平上皮非小細胞肺がん(NSCLC)で上皮成長因子受容体(EGFR)遺伝子変異あるいはALK遺伝子転座変異が認められない患者に対する、ペメトレキセド、プラチナ製剤の3剤併用療法を欧州委員会が承認したと発表した。同治療については、米国では2017年5月に迅速承認され、先月(2018年8月)には通常承認されている。

 

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of Patients with Metastatic Nonsquamous NSCLC, with No EGFR or ALK Genomic Tumor Aberrations

 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK positive mutations. This approval, the first in Europe for an anti-PD-1 therapy in combination with chemotherapy, is based on data from the pivotal Phase 3 KEYNOTE-189 trial in patients with metastatic nonsquamous NSCLC regardless of PD-L1 tumor expression status, which demonstrated a significant survival benefit for the combination of KEYTRUDA with chemotherapy as compared with standard-of-care chemotherapy alone – reducing the risk of death in these patients by half (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001).

 

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