FDA Approve Johnson & Johnson Combination Therapy

Johnson & Johnson have announced that 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 harbouring 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.”

“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. “This new regimen is a major advance over chemotherapy alone. 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, which specifically targets the EGFR exon 20 insertion mutation, has been approved.”

The FDA approval is based on positive results from the randomised, open-label Phase 3 PAPILLON study, which showed RYBREVANT plus chemotherapy resulted in a 61 percent reduction in the risk of disease progression or death compared to chemotherapy alone. Results also showed treatment with RYBREVANT plus chemotherapy improved objective response rate (ORR) and progression-free survival (PFS). Based on PAPILLON data, the National Comprehensive Cancer Network (NCCN ) updated its’ NCCN Clinical Practice Guidelines (NCCN Guidelines) to include a category 1 recommendation for amivantamab-vmjw (RYBREVANT) plus chemotherapy as a preferred first-line therapy for patients with NSCLC with EGFR exon 20 insertion mutations.

“We are redefining care for patients with non-small cell lung cancer by advancing innovative regimens that can be used early, with the goal of extending survival,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumours, Johnson & Johnson Innovative Medicine. “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.”