Janssen-Cilag International NV, a Johnson & Johnson subsidiary, announced a significant advancement in lung cancer therapy as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approving a subcutaneous formulation of RYBREVANT® (amivantamab). This approval targets adult patients battling advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations, offering a more convenient and safer treatment alternative.
Enhanced Patient Experience with Subcutaneous Administration
The newly recommended subcutaneous (SC) formulation of amivantamab is poised to transform the treatment regimen for NSCLC patients. Administered every two weeks after an initial four-week period, this method drastically reduces the time patients spend receiving treatment—from hours to mere minutes. Clinical trials, particularly the Phase 3 PALOMA-3 study, demonstrated that SC amivantamab maintains efficacy comparable to the traditional intravenous (IV) route while significantly decreasing infusion-related reactions by five times.
Clinical Trial Success and Safety Improvements
The PALOMA-3 study, involving 418 participants, confirmed that SC amivantamab is non-inferior to IV administration concerning pharmacokinetics and overall response rates. With an overall response rate of 30% in the SC group versus 33% in the IV group, the treatment not only achieved statistical equivalence but also enhanced patient safety by lowering the incidence of venous thromboembolic events. Additionally, the SC formulation showed a substantial reduction in infusion-related reactions, enhancing the overall tolerability of the treatment.
Key Inferences:
- Subcutaneous administration significantly improves patient convenience and reduces treatment time.
- Lower rates of infusion-related reactions enhance patient safety and treatment adherence.
- Reduced venous thromboembolic events indicate a safer profile for SC amivantamab.
The introduction of SC amivantamab marks a pivotal moment in the management of EGFR-mutated NSCLC, providing patients with a less burdensome and more effective treatment option. By minimizing the time and side effects associated with treatment administration, healthcare providers can offer a higher quality of life to those undergoing therapy.
Looking ahead, the adoption of subcutaneous therapies like RYBREVANT® could set a new standard in oncology, emphasizing patient-centric approaches without compromising clinical outcomes. This development not only underscores Janssen-Cilag’s commitment to innovation but also highlights the evolving landscape of cancer treatment, where efficiency and patient comfort take center stage.
Access to such advancements is crucial for improving survival rates and quality of life for lung cancer patients. Healthcare systems and providers should consider integrating SC amivantamab into treatment protocols to harness its full potential, ensuring that patients receive the most effective and humane care possible.
Furthermore, continued research and development in subcutaneous formulations could pave the way for similar breakthroughs in other cancer treatments, broadening the scope of patient-friendly therapies available in the future.

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