Summary
• Rybrevant (amivantamab-vmjw) was approved by the FDA for adults with non-small cell lung cancer who have EGFR mutations and have progressed on previous treatment.
• Efficacy of Rybrevant was evaluated in a clinical trial showing improved progression-free survival and response rates compared to standard treatment.
• Common side effects of Rybrevant include rash, fatigue, infusion-related reactions, and others.
• The drug was reviewed under Project Orbis, a global initiative for concurrent submission and review of oncology drugs.
• Healthcare professionals should report any adverse events related to Rybrevant and can seek assistance for investigational products through OCE’s Project Facilitate.
The Food and Drug Administration recently approved a new treatment called amivantamab-vmjw (Rybrevant) in combination with carboplatin and pemetrexed for adults with a specific type of non-small cell lung cancer that has worsened after previous treatment. This approval came after a successful clinical trial, where patients receiving the new treatment had longer progression-free survival compared to those receiving standard treatment alone. The most common side effects of the new treatment include rash, fatigue, and nausea.
This approval was part of Project Orbis, a collaboration between the FDA and international regulatory agencies to accelerate the review process for oncology drugs. Healthcare professionals are encouraged to report any serious side effects associated with this treatment to the FDA’s MedWatch Reporting System. For assistance with accessing investigational oncology products, professionals can contact OCE’s Project Facilitate. This new treatment option provides hope for patients with advanced non-small cell lung cancer, offering a potential improvement in outcomes and quality of life.
Oncology