- FDA approved monthly dosing for RYBREVANT FASPRO in February 2026.
- The treatment is for EGFR-mutated advanced non-small cell lung cancer.
- Monthly dosing matches efficacy of bi-weekly subcutaneous schedule.
- Adverse reaction rates are significantly lower than historical IV data.
FDA Approval
The FDA has approved a new monthly dosing schedule for RYBREVANT FASPRO, a combination of amivantamab and hyaluronidase-lpuj, for treating EGFR-mutated advanced non-small cell lung cancer (NSCLC). This approval simplifies the administration process, allowing patients to transition to monthly dosing as early as Week 5.
Clinical Efficacy
When combined with oral LAZCLUZE (lazertinib), the monthly dosing schedule delivers consistent outcomes with the previously approved bi-weekly subcutaneous dosing. The PALOMA-2 study presented at the 2025 World Conference on Lung Cancer demonstrated a high objective response rate in untreated patients.
Safety Profile
The safety profile of the monthly dosing is comparable to the bi-weekly schedule, with adverse reaction rates significantly lower than historical intravenous administration. Most adverse events were related to EGFR/MET inhibition, and no new safety signals were identified.
Patient Benefits
The new dosing schedule reduces administration time from hours to minutes and offers a fivefold reduction in administration-related reactions compared to intravenous delivery. This advancement supports treatment optimization and offers greater convenience for patients.
