Quick Summary
- Simplified Dosing: Patients can now transition to a once-monthly (every four weeks) subcutaneous injection after an initial lead-in period.
- Treatment Timeline: The regimen begins with weekly doses for the first four weeks (Weeks 1–4). Patients are eligible to switch to the monthly maintenance schedule starting as early as Week 5.
- Comparative Efficacy: Data from the PALOMA-2 study showed that the monthly schedule provides consistent clinical outcomes and efficacy (including a high objective response rate) compared to the previously approved bi-weekly subcutaneous schedule.
- Improved Patient Convenience: This is the only EGFR-targeted therapy that can be administered once a month, significantly reducing clinic visits and the overall treatment burden for patients.
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral LAZCLUZE® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule.
The decision, announced from the company’s Horsham, Pennsylvania headquarters, represents the latest evolution in a rapidly advancing treatment story for one of the most difficult-to-treat cancers and carries meaningful implications for the daily lives of patients who, until now, faced frequent clinic appointments simply to receive their therapy.
What Changed — and Why It Matters?
The newly approved dosing schedule allows patients to transition to monthly injections as early as Week 5, after an initial period of weekly injections during weeks one through four. jnj For a patient population often managing fatigue, side effects, and work or family responsibilities alongside their diagnosis, the reduction in clinic visits could be transformative.
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.
Dr. Danny Nguyen
This milestone builds upon the recent FDA approval of RYBREVANT FASPRO™ in December 2025, which transformed administration time from hours to minutes and offers a fivefold reduction in administration-related reactions (ARRs) compared to intravenous (IV) delivery.
The Science Behind the Approval: PALOMA-2 Data
The PALOMA-2 study (NCT05498428) is an open-label Phase 2 study evaluating the efficacy, safety, and pharmacokinetics of first-line SC amivantamab combined with LAZCLUZE® and/or chemotherapy in patients with EGFR-mutated advanced or metastatic NSCLC. The primary endpoint was objective response rate (ORR) as assessed by the investigator. PALOMA-2 Cohort 5 evaluated the efficacy, pharmacokinetics, and safety of first-line SC amivantamab Q4W (once every four weeks) plus LAZCLUZE® in EGFR-mutated NSCLC.
Recently presented at the 2025 World Conference on Lung Cancer (WCLC) in Barcelona, the data demonstrated that monthly RYBREVANT FASPRO™ dosing in combination with LAZCLUZE® delivered a high objective response rate in previously untreated, EGFR-mutated advanced NSCLC, with a significant reduction in ARRs compared to historical IV administration and consistent rates with bi-weekly SC delivery.
Key efficacy and safety metrics from the trial underscore the robustness of the monthly approach. ARRs were consistent with the bi-weekly dosing schedule (12% vs. 13% respectively) and fivefold lower when compared to historical IV administration (66%). Similarly, venous thromboembolic events (VTEs) were consistent with bi-weekly SC administration (13% vs. 11% with anticoagulation) and lower than historic IV data without anticoagulation (38%). No new safety signals were identified, only 8% of patients discontinued amivantamab due to treatment-related adverse events, and mean plasma concentration levels were consistent with historical IV and bi-weekly SC dosing data, supporting pharmacokinetic comparability.
Read More: Johnson & Johnson’s Imaavy Wins European Commission Approval for Generalized Myasthenia Gravis
Regulatory Standing and Clinical Guidelines
RYBREVANT FASPRO™ and RYBREVANT® are approved in the U.S. across four indications in EGFR-mutated NSCLC, including two in the first-line setting and two in the second-line, for patients with either exon 19 deletions, exon 21 L858R mutations, or exon 20 insertion mutations, as monotherapy or in combination with LAZCLUZE® or chemotherapy.
The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology include amivantamab with lazertinib as a Category 1 preferred option for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. The NCCN Guidelines for Central Nervous System Cancers also identify amivantamab-based regimens, including the combination with lazertinib, as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.
RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology, which enables the rapid subcutaneous delivery that defines this formulation
GSK Secures Japan Orphan Drug Designation for Risvutatug Rezetecan in Small-Cell Lung Cancer
GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data […]
Pfizer’s Talzenna + Xtandi Delivers Proven rPFS Breakthrough in HRR-Mutated mCSPC
Pfizer's landmark Phase 3 TALAPRO-3 trial confirms that the Talzenna Xtandi rPFS mCSPC combination markedly exceeds its pre-specified efficacy target — advancing PARP inhibition earlier […]
Eli Lilly Declares Powerful 2% A1C Reduction and 17% Weight Loss in Landmark Phase 3 Trial Results of Retatrutide
Quick Summary 2.0% Average A1C Reduction (primary endpoint achieved). 16.8% Body Weight Loss (36.6 lbs over 40 weeks). Improved Cardiovascular Markers (cholesterol, triglycerides, blood pressure). […]
ICOTYDE FDA Approval: J&J’s First-Line Oral Peptide Breakthrough for Plaque Psoriasis Treatment
ohnson & Johnson has announced FDA approval of ICOTYDE (icotrokinra), the first and only IL-23R targeted oral peptide designed for first-line systemic treatment of moderate-to-severe […]
Key Safety Considerations
The safety profile of monthly dosing was deemed comparable to the bi-weekly schedule. The most common adverse reactions (≥20%) observed in PALOMA-3 were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%).
Clinicians should be aware of several key monitored risks. Interstitial lung disease (ILD)/pneumonitis occurred in 6% of patients in PALOMA-3, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. VTEs occurred in 11% of patients; prophylactic anticoagulation for the first four months of treatment is recommended. Rash occurred in 80% of patients, including Grade 3 in 17%.
RYBREVANT FASPRO™ is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.
Last Modified:
