Johnson & Johnson Secures FDA Nod for New Lung Cancer Therapy, RYBREVANT and LAZCLUZE
Johnson & Johnson Secures FDA Nod for New Lung Cancer Therapy, RYBREVANT and LAZCLUZE
Johnson & Johnson (NYSE:JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.1,2
强生（纽交所：JNJ）今天宣布，美国食品和药物管理局（FDA）批准RYBREVANt（amivantamab-vmjw）加上LAZCLUZE（lazertinib）作为检测到EGFR外显子19缺失或外显子21 L858R替换突变的成人局部晚期或转移性非小细胞肺癌（NSCLC）的一线治疗方案。1,2
With this milestone, RYBREVANT plus LAZCLUZE becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.1,2 RYBREVANT is an EGFR- and MET*-directed bispecific antibody that engages the immune system, and LAZCLUZE is a highly selective, brain-penetrant, third-generation oral EGFR TKI**. RYBREVANT plus LAZCLUZE is the only multitargeted regimen targeting both the common EGFR mutations directly.1,2
随着这一里程碑的达成，RYBREVANt plus LAZCLUZE成为第一种并且唯一已获批用于EGFR突变NSCLC患者的一线治疗，具有证明优势的多靶向无化疗方案。1,2 RYBREVANt是一个EGFR-和MET-定向的双特异性抗体，可与免疫系统结合，而LAZCLUZE则是一种高度选择性的、可以穿过血脑屏障的第三代口服EGFR酪氨酸激酶抑制剂**。RYBREVANt加上LAZCLUZE是唯一直接靶向两种常见EGFR突变的多靶向方案。1,2