FDA Approves J&J's Rybrevant Combo for NSCLC with EGFR Exon 20 Insertions

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Johnson and Johnson announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved 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 FDA action converts the May 2021 accelerated approval of Rybrevant to a full approval based on the confirmatory phase 3 PAPILLON study.

“When aiming for the best possible treatment outcomes, 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,” said Joshua K. Sabari, M.D., an oncologist at NYU Langone’s Perlmutter Cancer Center and study investigator. “The results observed in the PAPILLON study showed significant improvement in progression-free survival, supporting the use of this regimen as the potential standard-of-care in the first-line treatment of these patients.”

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in NSCLC. Clinical data suggest that patients with EGFR exon 20 insertion mutations generally have limited benefit from third-generation EGFR tyrosine kinase inhibitors and chemotherapy. NSCLC caused by EGFR exon 20 insertion mutations has a worse prognosis and shorter survival than lung cancer caused by other EGFR mutations.

"Each treatment is available for patients with lung cancer. It's new or an option, but it can be a way of life." "The approval of Libvant and chemotherapy represents the first line of treatment for patients with non-small cell lung cancer that is not low-risk. Breast cancer is the translocation of an EGFR exon 20 insertion," said Marcia Horn, chief executive of the Exxon Group. He is a member of the International Advocacy Network (ICAN). "This new drug is a big step forward compared to chemotherapy alone. We directly observed in the PAPILLON study an increase in the survival of patients in the Exon 20 group who received Rybrevant and chemotherapy, saying that this popular treatment can target the EGFR exon." They showed that they were targeting it.” I heard that insertion mutations were approved