유럽연합 집행위원회는 EGFR 변이 진행성 비소세포폐암 환자의 1차 치료제로 J&J의 RYBREVANT®(amivantamab)와 유한양행이 개발해 J&J에 라이선스아웃한LAZCLUZE®(lazertinib)와의 병용 요법을 승인함.
The European Commission has approved the combination of RYBREVANT® (amivantamab) and LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or L858R substitution mutations. This approval is based on results from the Phase 3 MARIPOSA study, which demonstrated that the amivantamab and lazertinib combination significantly reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy. The study also showed a nine-month improvement in median duration of response for patients receiving the combination therapy. This chemotherapy-free regimen offers a new standard of care for patients with EGFR-mutated advanced NSCLC. In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (marketed as LACLAZA in Korea). LAZCLUZE™ is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. The European Commission has approved the combination of RYBREVANT® (amivantamab) and LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or L858R substitution mutations. This approval is based on results from the Phase 3 MARIPOSA study, which demonstrated that the amivantamab and lazertinib combination significantly reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy. The study also showed a nine-month improvement in median duration of response for patients receiving the combination therapy. This chemotherapy-free regimen offers a new standard of care for patients with EGFR-mutated advanced NSCLC. In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (marketed as LACLAZA in Korea). LAZCLUZE™ is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.