March 1, 2024 – In a significant advancement for lung cancer treatment, the Food and Drug Administration (FDA) has approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) in combination with carboplatin and pemetrexed. This new therapy is designated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as confirmed by an FDA-approved diagnostic test.
Traditional Approval Granted for Amivantamab-vmjw
The FDA has also issued traditional approval for amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. This approval is specifically for those whose disease has progressed on or after platinum-based chemotherapy. This follows the accelerated approval previously granted for this indication, marking a pivotal step forward in targeted lung cancer therapy.
Amivantamab Combo in EGFR Exon 20 NSCLC: PAPILLON Results Nicolas Girard, MD – Video Exclusive
PAPILLON Trial Demonstrates Significant Efficacy
The approval was based on the results from the PAPILLON trial (NCT04538664), a randomized, open-label multicenter study involving 308 patients. Participants were randomly assigned to receive either amivantamab-vmjw with carboplatin and pemetrexed or carboplatin and pemetrexed alone. The trial’s major efficacy outcome, progression-free survival (PFS), was assessed by a blinded independent central review (BICR), with overall survival (OS) as a crucial secondary outcome measure.
The combination of amivantamab-vmjw with carboplatin and pemetrexed resulted in a statistically significant improvement in PFS compared to the control group, showcasing a hazard ratio of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). The median PFS for the treatment group was 11.4 months, compared to 6.7 months for those receiving carboplatin and pemetrexed alone.
Monitoring and Managing Adverse Reactions
Common adverse reactions experienced by more than 20% of patients included rash, nail toxicity, stomatitis, infusion-related reactions, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting. The recommended dose of amivantamab-vmjw is determined by body weight, with specific dosage information provided in the prescribing information.
International Collaboration and Expedited Review
This review was conducted under Project Orbis, part of the FDA Oncology Center of Excellence’s initiative to facilitate concurrent submission and review of oncology drugs among international partners. The FDA collaborated with the Brazilian Health Regulatory Agency (ANVISA) and Health Canada for this review, with applications still under review by other regulatory agencies.
Additionally, the Real-Time Oncology Review (RTOR) pilot program and the Assessment Aid were utilized to streamline the review process, allowing the FDA to approve the application four weeks ahead of the goal date. This application was also granted priority review, underlining the FDA’s commitment to expediting the development and review of drugs that address serious conditions.
For further details, full prescribing information for Rybrevant will be made available, providing healthcare professionals with the necessary information to deliver this promising new therapy to patients in need.
Reference Links:
FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications
RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations: https://www.jnj.com/media-center/press-releases/rybrevant-amivantamab-vmjw-in-combination-with-chemotherapy-is-the-first-fda-approved-therapy-for-first-line-treatment-of-patients-with-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations
OncologyTube Related Videos and Articles:
Amivantamab Combo in EGFR Exon 20 NSCLC: PAPILLON Results Nicolas Girard, MD: https://oncologytube.com/amivantamab-combo-in-egfr-exon-20-nsclc-papillon-results-nicolas-girard-md/