FDA 批准 RYBREVANT ®联合化疗治疗具有 EGFR 外显子 20 插入突变的一线 NSCLC。 FDA approves RYBREVANT® with chemotherapy for first-line NSCLC with EGFR exon 20 insertion mutations.
强生公司的 RYBREVANT® (amivantamab-vmjw) 联合化疗是 FDA 批准的第一个用于一线治疗 EGFR 外显子 20 插入突变的非小细胞肺癌 (NSCLC) 患者的疗法。 Johnson & Johnson's RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy is the first FDA-approved therapy for first-line treatment of patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. 此次批准基于 3 期 PAPILLON 研究结果，该研究结果表明，对于既往未经治疗的 EGFR 外显子 20 插入突变的 NSCLC 患者，与单独化疗相比，RYBREVANT 联合化疗可将疾病进展或死亡风险降低 61%。 The approval is based on the Phase 3 PAPILLON study results, which demonstrated that RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61% versus chemotherapy alone in previously untreated NSCLC patients with EGFR exon 20 insertion mutations. NCCN 肿瘤学临床实践指南（NCCN 指南）已更新其建议，将 RYBREVANT® 联合化疗纳入具有 EGFR 外显子 20 插入突变的 NSCLC 患者的首选一线治疗方案。 The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) have updated their recommendations to include RYBREVANT® plus chemotherapy as a preferred first-line regimen for patients with NSCLC with EGFR exon 20 insertion mutations.