The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review.
Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the treatment of non-small cell lung cancer (NSCLC) with EGFR gene exon 20 insertion mutations in the United States. The drug was granted Breakthrough Therapy Designation (BTD) in China in September 2020 for use in metastatic or surgically unresectable NSCLC with the same mutation, particularly for patients who have progressed during or after platinum-based dual drug chemotherapy or are intolerant to such treatment. It was filed for marketing in China for advanced or metastatic EGFR exon 20 mutant NSCLC in October 2023.
Lazertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI) developed by South Korea’s Yuhan Corporation, is under J&J’s rights outside South Korea. The drug was approved in January 2021 in South Korea for the treatment of EGFR T790M mutation-positive locally advanced or metastatic NSCLC in patients previously treated with EGFR-TKI, marketed under the name Leclaza. It was filed for marketing in the U.S. in December 2023 for use in first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or L858R substitution mutation in combination with amivantamab.- Flcube.com
