The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R substitution mutations. The submission is backed by Phase III data indicating that this chemotherapy-free regimen markedly improves progression-free survival (PFS) over osimertinib therapy.
Rybrevant has previously received conditional approval in the US for the treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and is currently under review in combination with chemotherapy for this indication. The anti-EGFR/MET biologic is also in clinical development for several other NSCLC indications and is being evaluated for a subcutaneous formulation.- Flcube.com
