Janssen submits Rybrevant's extension of indication in advanced NSCLC to the EMA

Janssen has announced the submission of a type II extension of indication application to the EMA for Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor (TKI).

This submission is supported by data from the Phase 3 MARIPOSA-2 (NCT04988295) study, evaluating the efficacy and safety of amivantamab and chemotherapy in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib.

The amivantamab plus chemotherapy arm met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS), versus chemotherapy alone, reducing the risk of disease progression or death by 52 percent (Hazard Ratio [HR]= 0.48; 95 percent Confidence Interval [CI], 0.36–0.64; P<0.001).

Reference link: Janssen press release