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sBLA and NDA Submitted to FDA for Amivantamab and Lazertinib in EGFR-Mutant NSCLC

*December 2023*

Note: Amivantamab and Lazertinib may soon receive approval as a first-line treatment for EGFR+ lung cancer.

A supplemental biologics license application and new drug application seeking the approval of amivantamab-vmjw (Rybrevant) plus lazertinib as frontline therapy for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test, have been submitted to the FDA.1

Both applications were based on data from the phase 3 MARIPOSA trial (NCT04487080) in which the combination of amivantamab and lazertinib led to a significant improvement in progression-free survival (PFS) vs osimertinib (Tagrisso) alone in patients with newly diagnosed advanced NSCLC with classical EGFR mutations.2

“The combination of [amivantamab] 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,” Kiran Patel, MD, vice president, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine, stated in a news release.1 “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.”

MARIPOSA is a randomized phase 3 trial evaluating the EGFR- and MET-targeted bispecific antibody, amivantamab, plus the oral, third-generation EGFR TKI, lazertinib, vs osimertinib and lazertinib monotherapy. Read more.