Johnson & Johnson Secures FDA Nod for Monthly Rybrevant Faspro in EGFR-Mutated NSCLC
FDA approved a monthly subcutaneous dosing regimen for Johnson & Johnson’s Rybrevant Faspro combined with oral lazertinib in first-line EGFR-mutated advanced NSCLC, enabling patients to switch from bi-weekly injections following initial treatment. Monthly dosing matches bi-weekly efficacy, reduces administration-related reactions fivefold versus IV, and yielded high ORR in PALOMA-2 data.
1. FDA Approves Monthly Dosing Schedule
The FDA approved a monthly subcutaneous dosing regimen for Rybrevant Faspro combined with oral lazertinib in first-line EGFR-mutated advanced NSCLC, enabling patients to switch from bi-weekly injections following initial treatment.
2. Clinical Data Support Efficacy and Safety
PALOMA-2 trial data demonstrated that monthly dosing delivered a high objective response rate and matched the efficacy of bi-weekly subcutaneous administration, while reducing administration-related reactions fivefold compared to intravenous delivery.