JNJ Receives Positive CHMP Opinion For Rybrevant For Treatment Of Patients With Advanced NSCLC

(RTTNews) - Johnson & Johnson's (JNJ) subsidiary, Janssen-Cilag International NV, announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended the approval of Rybrevant also known as amivantamab for the first-line treatment of adult patients with advanced non-small cell lung cancer also known as NSCLC.

The CHMP recommendation is based on data from the Phase 3 PAPILLON study, which demonstrated that Rybrevant plus chemotherapy significantly enhanced progression-free survival in adult patients compared to chemotherapy alone.

This favorable CHMP opinion positions Rybrevant as a new treatment option and the first fully human EGFR-MET bispecific antibody for the initial management of EGFR exon 20 insertion-mutated NSCLC.