FDA approved a simplified, once-monthly dosing schedule for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) when used in combination with Lazcluze (lazertinib) as a first-line treatment for patients with EGFR-mutated advanced non-small cell lung cancer.

The updated schedule is expected to allow patients receiving the subcutaneous formulation to transition to monthly dosing as early as five weeks into treatment.

According to Johnson & Johnson, clinical data displays how the monthly regimen delivers outcomes consistent with the previously approved every-two-week subcutaneous dosing schedule.¹

The approval positions the once-monthly regimen as an alternative scheduling option intended to maintain clinical outcomes while further simplifying treatment logistics in a competitive segment of the lung cancer market.¹

Rybrevant Faspro is administered subcutaneously and is designed to target EGFR and MET pathways.¹ The Paloma-2 trial evaluated first-line subcutaneous amivantamab combined with Lazcluze in patients with EGFR-mutated advanced or metastatic disease, with objective response rate as the primary endpoint.

Why did FDA approve the new dosing schedule for Rybrevant Faspro?

The recent approval builds on a prior FDA decision that converted administration of the therapy from intravenous infusion to a subcutaneous injection, reducing treatment time from hours to minutes.²

Johnson & Johnson has reported that the subcutaneous formulation is associated with a fivefold reduction in administration-related reactions compared with historical intravenous delivery.

“A monthly dosing schedule offers patients convenience without sacrificing efficacy,” said Danny Nguyen, M.D., assistant clinical professor for the department of medical oncology & therapeutics research at City of Hope, and principal investigator for the Paloma-III and Mariposa studies. “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.”

Data supporting the approval was presented at the 2025 World Conference on Lung Cancer, including data from the Phase II Paloma-II study of monthly Rybrevant Faspro in combination with Lazcluze, which achieved a high objective response rate in previously untreated patients with EGFR-mutated advanced non-small cell lung cancer.¹

The study also showed administration-related reaction rates comparable to bi-weekly subcutaneous dosing and substantially lower than those reported historically with intravenous administration.

The safety profile of the monthly regimen was consistent with the bi-weekly schedule. Administration-related reactions occurred in 12% of patients receiving monthly dosing versus 13% with the every-two-week schedule, compared with 66% in historical intravenous data.³

Venous thromboembolic events were reported in 13% of patients on the monthly schedule, versus 11% with bi-weekly dosing with anticoagulation, and 38% in historic intravenous data without anticoagulation.³

“This latest milestone represents the culmination of our unwavering efforts and commitment to fundamentally redefine the way we treat patients with EGFR-mutated non-small cell lung cancer,” said Mahadi Baig, M.D., M.H.C.M., vice president, U.S. Medical Affairs, Johnson & Johnson. “Building on unmatched overall survival and regimens that support proactive side effect management, this once-monthly injection now delivers the simplest and fastest combination therapy for patients with EGFR-mutated non-small cell lung cancer.”

Sources

1. FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month Johnson & Johnson 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. 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) Johnson & Johnson December 17, 2025 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. Paloma-2 Study: Subcutaneous Amivantamab Every 4 Weeks Plus Lazertinib Shows High Response Rate in EGFR-Mutated NSCLC International Association for The Study of Lung Cancer September 9, 2025 https://www.iaslc.org/iaslc-news/press-release/paloma-2-study-subcutaneous-amivantamab-every-4-weeks-plus-lazertinib