Johnson & Johnson has announced the approval by the US Food and Drug Administration (FDA) of RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. 

This approval, following a priority review, builds upon the accelerated approval of RYBREVANT® in May 2021, based on the Phase 3 PAPILLON study results.

Dr. Joshua K. Sabari, an oncologist at NYU Langone's Perlmutter Cancer Center and a study investigator, remarked, "A targeted approach should be used in the first line for patients with EGFR exon 20 insertion mutations, as this is a commonly applied practice for patients with NSCLC harboring other molecular driver alterations."

The Phase 3 PAPILLON study demonstrated that RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in previously untreated NSCLC with EGFR exon 20 insertion mutations. 

Marcia Horn, Executive Director of the Exon 20 Group and CEO of ICAN, International Cancer Advocacy Network, noted, "We've seen first-hand the extended survival that Exon 20 Group patients experienced on RYBREVANT plus chemotherapy in the PAPILLON study, and we're delighted that this historic treatment option has been approved."

The National Comprehensive Cancer Network® (NCCN®) updated its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) to recommend RYBREVANT® plus chemotherapy as a preferred first-line regimen for patients with NSCLC with EGFR exon 20 insertion mutations.

Dr. Kiran Patel, Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine, expressed, "RYBREVANT plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations. We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio."

RYBREVANT® is associated with warnings and precautions, including infusion-related reactions, interstitial lung disease/pneumonitis, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity. The most common adverse reactions observed were rash, nail toxicity, stomatitis, infusion-related reactions, fatigue, and edema.