FDA Approves Rybrevant for Third NSCLC Indication This Year

Third Approval for Rybrevant:
The FDA has approved Rybrevant (amivantamab-vmjw) for its third indication in non-small cell lung cancer (NSCLC) this year, specifically in combination with standard of care chemotherapy for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).

Clinical Trial Basis:
The approval is based on the Phase III MARIPOSA-2 study, which showed that Rybrevant in combination with chemotherapy reduced the risk of disease progression or death by 52% compared to chemotherapy alone.

Previous Approvals:
This year, Rybrevant has also been approved for the first-line treatment of NSCLC with EGFR exon 20 insertion mutations in combination with chemotherapy (March 1, 2024) and for the first-line treatment of NSCLC with EGFR exon 19 deletions or L858R substitution mutations in combination with LAZCLUZE (August 20, 2024).

Significance:
This approval provides an important new treatment option for patients with advanced EGFR-mutated NSCLC, addressing common mechanisms of treatment resistance to third-generation EGFR TKIs.

Regulatory Milestones:
Johnson & Johnson has submitted additional applications for Rybrevant, including a subcutaneous formulation in combination with LAZCLUZE for all currently approved or submitted indications of IV Rybrevant in certain patients with NSCLC, which received Priority Review designation from the FDA in August 2024.