FX.co ★ Johnson & Johnson's Rybrevant Gets FDA Approval For Lung Cancer Treatment

Johnson & Johnson declared on Friday that its medicine, Rybrevant, has received approval from the U.S. Food and Drug Administration (FDA) to be used in conjunction with chemotherapy as an initial treatment for patients suffering from non-small cell lung cancer.

According to the company, the FDA has greenlit Rybrevant, in combination with chemotherapy, as the primary treatment for patients who have locally advanced or metastatic non-small cell lung cancer. This specific type of cancer features mutations in the epidermal growth factor receptor (EGFR) exon 20, which must be identified using an FDA-approved test.

The recent approval from the FDA substantiates Rybrevant's accelerated approval, which was granted in May 2021, confirming it as a fully-approved treatment. This decision follows the supporting evidence provided by the Phase 3 Papillon study.

Joshua K. Sabari, MD, an oncologist at NYU Langone's Perlmutter Cancer Center and study investigator, stated, "In pursuit of the most optimal treatment outcomes, a targeted approach should be the first course of action for patients with EGFR exon 20 insertion mutations. This is typically the strategy for patients with NSCLC who carry other molecular driver alterations. The significant improvement in progression-free survival displayed by the results of the Papillon study supports the use of this regimen as a potential standard-of-care for initial treatment of these patients."

Lung cancer is one of the highest occurring forms of cancer worldwide, with non-small cell lung cancer accounting for 80 to 85 percent of all cases. Alterations in EGFR are the most frequently observed actionable driver mutations in NSCLC. Clinical evidence suggests that patients with EGFR exon 20 insertion mutations typically experience restricted benefits from currently approved third-generation EGFR tyrosine kinase inhibitors and chemotherapy.