Europe - JnJ submits extension of indication to EMA for Rybrevant in locally advanced or metastatic NSCLC with EGFR ex19del or L858R mutations

JnJ has announced the submission to the EMA of an extension of indication appliation for Rybrevant (amivantamab) in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R mutations and as monotherapy in adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy based on the PALOMA-3 data.

PALOMA-3 (NCT05388669), which enrolled 418 patients, is a randomized, open-label Phase 3 study evaluating the pharmacokinetics (PK), efficacy and safety of subcutaneous amivantamab (administered via manual injection) combined with lazertinib compared to IV amivantamab and lazertinib in patients with EGFR-mutated advanced or metastatic NSCLC after progression on osimertinib and chemotherapy. 

Reference link: JnJ press release