The European Commission (EC) has approved a Marketing Authorization (MA) for Lazcluze (lazertinib), in combination with Rybrevant amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
The MA was submitted by Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen-Cilag. This latest decision follows a corresponding EC approval in December 2024 of a Type II variation extension of indication for the bispecific antibody amivantamab, in combination with lazertinib, for the first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
The newly approved combination could help J&J compete more effectively with AstraZeneca’s (LSE: AZN) oral EGFR inhibitor, Tagrisso, as Rybrevant’s intravenous form requires hours for administration, compared to the five to seven minutes needed for the subcutaneous version.
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