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
強生（紐交所：JNJ）今天宣佈，美國食品和藥物管理局（FDA）批准RYBREVANt（amivantamab-vmjw）加上LAZCLUZE（lazertinib）作爲檢測到EGFR外顯子19缺失或外顯子21 L858R替換突變的成人局部晚期或轉移性非小細胞肺癌（NSCLC）的一線治療方案。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
隨着這一里程碑的達成，RYBREVANt plus LAZCLUZE成爲第一種並且唯一已獲批用於EGFR突變NSCLC患者的一線治療，具有證明優勢的多靶向無化療方案。1,2 RYBREVANt是一個EGFR-和MET-定向的雙特異性抗體，可與免疫系統結合，而LAZCLUZE則是一種高度選擇性的、可以穿過血腦屏障的第三代口服EGFR酪氨酸激酶抑制劑**。RYBREVANt加上LAZCLUZE是唯一直接靶向兩種常見EGFR突變的多靶向方案。1,2