FDA Approves Once-Monthly Dosing Schedule for Amivantamab and Hyaluronidase-lpuj in EGFR-Mutated NSCLC

The FDA approved a new once-monthly dosing schedule for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro; Johnson and Johnson), marking a major advancement in treatment convenience for patients with epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC). This approval does not represent a new indication for amivantamab but instead focuses on optimizing administration through extended dosing intervals and subcutaneous delivery.¹

By reducing treatment frequency and time spent in clinical settings, this milestone reflects a growing emphasis on patient-centered oncology care.

Addressing Treatment Burden in EGFR-Mutated Lung Cancer

Patients whose NSCLC carries an EGFR mutation are generally on targeted therapy for extended periods in order to keep the disease under control. Long-term targeted therapies have certainly boosted survival rates; however, continuous screening visits and the prolonged infusion times can place additional burdens on patients physically, emotionally, and logistically. Traditional intravenous regimens may require hours of administration and close monitoring, limiting flexibility for patients who are managing work, family responsibilities, and treatment-related fatigue.¹

The newly approved once-monthly dosing schedule aims to address these issues. Clinicians, by increasing the time between doses, can help to lessen the treatment burden and at the same time continue to maintain the therapeutic efficacy. For patients with NSCLC, fewer appointments and shorter visits could help to enhance their quality of life issues.

According to Johnson & Johnson, this regimen is the only EGFR-targeted therapy that allows for a once-monthly administration.¹

Subcutaneous Delivery and Enhanced Convenience

Amivantamab is a subcutaneous treatment that contains hyaluronidase, an enzyme that helps amivantamab to be quickly absorbed into the bloodstream. This method can bring the drug straight to the body very effectively without long IV drug infusions. As highlighted in a Pharmacy Times report, administration can be completed in approximately 5 minutes, representing a substantial reduction in chair time compared with traditional infusion-based therapies.³

Shorter administration times also benefit oncology clinics by improving workflow efficiency and reducing congestion in infusion centers. Pharmacists and nurses can manage patient volume more effectively, while patients experience less disruption to daily activities. This shift toward streamlined delivery models reflects broader efforts to modernize cancer care and improve access to advanced therapies.

Supporting Treatment Adherence and Persistence

Extended dosing intervals may play an important role in promoting long-term adherence and treatment persistence. Patients receiving frequent infusions may experience cumulative fatigue, transportation challenges, or scheduling conflicts that interfere with consistent therapy. By contrast, monthly dosing may enhance patients’ ability to remain on treatment over time.¹

Danny Nguyen, MD, assistant clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope, emphasized the significance of this approach, stating, “A monthly dosing schedule offers patients convenience without sacrificing efficacy… With a flexible schedule that reduces time in the clinic, patients may be able to stay on therapy longer and free up time to focus on the moments that matter most.”¹ This perspective highlights the importance of balancing clinical outcomes with patient experience.

Implications for Oncology Pharmacists

For oncology pharmacists, the approval of the once-monthly regimen introduces important practice considerations. Pharmacists must ensure appropriate storage, handling, and administration of the subcutaneous formulation while educating patients on injection-site reactions, potential adverse effects, and adherence requirements.³

Extended dosing intervals also create new opportunities for patient counseling and monitoring. Pharmacists can use monthly visits to assess tolerability, reinforce medication adherence, and coordinate supportive care interventions. Additionally, reduced infusion times may allow pharmacy teams to optimize staffing and resource allocation in high-volume oncology settings.

Conclusion

The approval of a once-monthly dosing schedule for amivantamab represents a meaningful advancement in the management of EGFR-mutated NSCLC. By combining subcutaneous delivery with extended dosing intervals, this regimen addresses longstanding challenges related to treatment burden, adherence, and clinic resource utilization.^1-3

For oncology pharmacists and multidisciplinary care teams, this development offers new opportunities to support patient-centered care while maintaining high clinical standards. As targeted therapies continue to evolve, innovations in dosing and delivery will play a critical role in optimizing long-term outcomes and quality of life for patients with NSCLC.

REFERENCES

1. Johnson & Johnson. FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month. Published February 17, 2026. Accessed February 17, 2026. https://www.jnj.com/media-center/press-releases/fda-approves-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-as-the-only-egfr-targeted-therapy-that-can-be-administered-once-a-month

2. Johnson & Johnson. U.S. FDA approval of RYBREVANT FASPRO™ enables the simplest, shortest administration time for a first-line combination regimen when combined with Lazcluze (lazertinib). Published December 17, 2025. Accessed February 17, 2026. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-enables-the-simplest-shortest-administration-time-for-a-first-line-combination-regimen-when-combined-with-lazcluze-lazertinib

3. Antrim A. Pharmacy Times. FDA approves amivantamab and hyaluronidase-lpuj: revolutionizing lung cancer treatment with 5-minute subcutaneous delivery. Published December 18, 2025. Accessed February 17, 2026. https://www.pharmacytimes.com/view/fda-approves-amivantamab-and-hyaluronidase-lpuj-revolutionizing-lung-cancer-treatment-with-5-minute-subcutaneous-delivery