FDA Approves Rybrevant as First-Line Treatment for NSCLC


The FDA also granted traditional approval to amivantamab-vmjw for adults whose disease has progressed on or after platinum-based chemotherapy.

The FDA approved amivantamab-vmjw (Rybrevant, Janssen Biotech Inc) with carboplatin and pemetrexed for the first-line treatment of 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, according to a statement from the agency.1

3d rendered medically accurate illustration of lung cancer | Image Credit: Sebastian Kaulitzki - stock.adobe.com

Image Credit: Sebastian Kaulitzki - stock.adobe.com

Further, the FDA also granted traditional approval to amivantamab-vmjw for adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, detected by an FDA-approved test, for those whose disease has progressed on or after platinum-based chemotherapy. This indication was previously granted accelerated approval.1

Amivantamab-vmjw is a bispecific EGFR-directed and MET receptor-directed antibody, according to the prescribing label. The recommended dose is based on baseline body weight and administered intravenously. It was approved in the 250 mg/7 mL strength in a single-dose vial.2

About The PAPILLON Clinical Trial

Trial Name: A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

ClinicalTrials.gov ID: NCT04538664

Sponsor: Janssen Research & Development

Completion Date (Estimated): January 2026

The efficacy of the drug was evaluated in the PAPILLON trial, which was randomized, open-label, and multi-centered, according to the press release. In the study, investigators included 308 individuals and randomized treatment 1:1 with either amivantamab-vmjw, carboplatin, and pemetrexed or carboplatin and pemetrexed. The main efficacy outcome measure was progression free survival (PFS) and the secondary outcome was overall survival (OS).1

Investigators found that the amivantamab-vmjw combination demonstrated a statistically significant improvement in PFS compared to the 2-agent combination, with a hazard ratio of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001), according to the press release. The median PFS was 11.4 months and 6.7 months, respectively. At the current analysis, the OS was immature with 44% of pre-specified deaths in the final analysis and no trends toward a detriment, the results showed.1

Furthermore, there was an overall response rate of 73% with amivantamab-vmjw compared with 47% for chemotherapy alone in October 2023, according to a press release from Janssen. In the same press release, the company said the median PFS2 was also longer with the study drug, supporting the use of the therapy in the first line. Out of 94 individuals receiving chemotherapy alone, 71 received amivantamab-vmjw in their subsequent treatment in the second-line.3

The most common adverse events with 20% or more were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting, according to the press release.1

The results of the PAPILLON clinical trial were previously presented at the European Society of Medical Oncology 2023 Congress.3 The application previously received priority review.1 Janssen also plans to evaluated amivantamab-vmjw in other clinical trials, including CHRYSALIS, MARIPOSA, POLOMA, and additional studies, according to a press release in October 2023.3

  1. FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications. News release. FDA. March 1, 2024. Accessed March 1, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications
  2. Amivantamab-vmjw (Rybrevant)] label. [Janssen Biotech Inc]. Accessed March 1, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf
  3. New Data from Phase 3 PAPILLON Study Show Rybrevant (amivantamab-vmjw) Plus Chemotherapy Resulted in 60% Reduction in Risk of Disease Progression or Death in Patients with Previously Untreated EGFR Exon 20 Insertion Mutation-Positive NSCLC. News release. Janssen. October 21, 2023. Accessed March 1, 2024. https://www.janssen.com/new-data-phase-3-papillon-study-show-rybrevantr-amivantamab-vmjw-plus-chemotherapy-resulted-60
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