J&J submits sBLA and NDA to FDA for approval of Rybrevant combo in NSCLC

Johnson & Johnson announced the submission of a supplemental Biologics License Application, sBLA, to the U.S. Food and Drug Administration, FDA, together with a New Drug Application, NDA, seeking the approval of RYBREVANT or amivantamab-vmjw, in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer, NSCLC, with epidermal growth factor receptor EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. Based on the Phase 3 MARIPOSA study, this marks the third submission from the RYBREVANT clinical development program in four months, following sBLA submissions for MARIPOSA-2 and PAPILLON. “The combination of RYBREVANT(R) and lazertinib demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to osimertinib in patients with previously untreated EGFR-mutated NSCLC. This remains an area of high unmet need as patients often experience treatment resistance and disease progression on currently available therapies,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “We believe this targeted, chemotherapy-free regimen may have the potential to transform the treatment of EGFR-mutated NSCLC, and we look forward to working with the FDA in review of these applications.”