Johnson & Johnson's subsidiary, Janssen-Cilag International NV, revealed on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has advocated for the approval of Rybrevant, also recognized as amivantamab. The drug is proposed for the primary treatment of adult patients afflicted with advanced non-small cell lung cancer (NSCLC).
This recommendation by CHMP is founded on the evidence from the Phase 3 PAPILLON study, which provided clear evidence that Rybrevant, when combined with chemotherapy, substantially improves progression-free survival in adult patients compared to using only chemotherapy.
This positive appraisal from CHMP positions Rybrevant as a revolutionary treatment alternative. It also stands as the first fully human EGFR-MET bispecific antibody for the initial management of EGFR exon 20 insertion-mutated NSCLC.
