FDA Approves Once‑Monthly SC RYBREVANT FASPRO: Implications for Clinic Operations

A Johnson & Johnson press release reports that the FDA has approved a new, simplified once-monthly subcutaneous dosing schedule for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) when administered in combination with oral LAZCLUZE® (lazertinib) for the first-line treatment of EGFR-mutated advanced NSCLC.

In the announcement, the company states that, under the newly approved schedule, patients can transition to monthly dosing as early as Week 5.

The release frames the update in operational terms, emphasizing fewer treatment visits. It also reiterates that the subcutaneous formulation transformed administration time “from hours to minutes” compared with prior intravenous delivery, positioning time in clinic and convenience as notable features of the delivery approach.

For pharmacokinetic support, the company reports that mean plasma concentration levels with the once-monthly subcutaneous schedule were consistent with historical data from intravenous administration and with the previously approved bi-weekly subcutaneous dosing schedule. The press release presents this as pharmacokinetic comparability across dosing approaches rather than a new exposure target or mechanistic rationale. In the announcement’s narrative, the PK statement serves as the reported basis for extending the dosing interval while keeping systemic exposure aligned with prior experience.

Safety statements cite findings from PALOMA-2 and referenced cohorts, describing the safety profile of monthly dosing as comparable to administration every two weeks. Administration-related reactions (ARRs) are described as consistent between monthly and bi-weekly subcutaneous schedules (12% vs 13%, respectively) and as fivefold lower than historical intravenous administration figures cited in the release (66%). Venous thromboembolic event (VTE) rates are described as consistent with bi-weekly subcutaneous administration (13% vs 11% with anticoagulation) and lower than historic intravenous data without anticoagulation (38%). The release states that no new safety signals were identified.

In describing the evidence base, the press release points to PALOMA-2 data supporting monthly RYBREVANT FASPRO™ dosing in combination with LAZCLUZE®, and states that monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous dosing schedule. It also places the update in the context of the earlier authorization for the subcutaneous formulation and reiterates that the monthly schedule is intended to reduce treatment visits while maintaining established safety and efficacy in the combination setting.

Taken together, the announcement presents an FDA-approved monthly subcutaneous dosing schedule alongside company-reported pharmacokinetic and safety comparability and reduced treatment visits.

Key Takeaways:

• The press release reports FDA approval of a once-monthly subcutaneous dosing schedule for RYBREVANT FASPRO in combination with LAZCLUZE for first-line EGFR-mutated advanced NSCLC, with transition to monthly dosing described as possible as early as Week 5.
• The company states that mean plasma concentrations with monthly subcutaneous dosing were consistent with historical intravenous and bi-weekly subcutaneous dosing data.
• The release reports comparable safety findings versus bi-weekly subcutaneous administration, including ARR and VTE comparisons, and states that no new safety signals were identified.