FDA Grants Full Approval to Rybrevant in Lung Cancer

The FDA has converted the accelerated approval of Rybrevant (amivantamab-vmjw) to full as the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Rybrevant is indicated to be used in combination with chemotherapy (carboplatin-pemetrexed) to treat patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Non-small-cell lung cancer makes up at about 80% to 85% of all lung cancer cases. The most common mutation in NSCLC is an alternation in EGFR, which is a receptor tyrosine kinase that controls cell growth and division.

“For patients with lung cancer and their families, each breakthrough in treatment provides not only a new option, but a potential lifeline. The approval of Rybrevant plus chemotherapy heralds a promising new first-line treatment option for patients newly diagnosed with non-small cell lung cancer where their driver mutation is an EGFR exon 20 insertion," said Marcia Horn, executive director of the Exon 20 Group and CEO of ICAN, International Cancer Advocacy Network, said in a press release.

Developed by Johnson & Johnson, Rybrevant is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity. It received accelerated approval by the FDA in May 2021.

The cost for Rybrevant intravenous solution is about $3,677 for a supply of 7 milliliters, according to Drugs.com. Johnson & Johnson offers a copay assistance program for commercially insured patients for $5 per infusion, with a $26,000 maximum program benefit per calendar year, as well as assistance for those without insurance through the Johnson & Johnson Patient Assistance Foundation.

The full approval is based on the results of the confirmatory phase 3 PAPILLON study. The study showed that Rybrevant plus chemotherapy resulted in a 61% reduction in the risk of disease progression or death compared with chemotherapy alone. Results also showed treatment with Rybrevant plus chemotherapy improved objective response rate (ORR) and progression-free survival (PFS). These data were presented at the European Society of Medical Oncology (ESMO) 2023 Congress and published in The New England Journal of Medicine. 

Additionally, based on the results of the PAPILLON study, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include a category 1 recommendation for Rybrevant plus chemotherapy as a preferred first-line therapy for patients with NSCLC with EGFR exon 20 insertion mutations.