HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved a new monthly dosing schedule for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), to be used in combination with oral LAZCLUZE® (lazertinib) for the first-line treatment of epidermal growth factor receptor-mutated advanced non-small cell lung cancer.
The company said the once-monthly subcutaneous dosing schedule delivers outcomes consistent with the previously approved biweekly dosing regimen and allows patients to transition to monthly treatment as early as Week 5.
According to Johnson & Johnson, data presented at the 2025 World Conference on Lung Cancer showed that monthly RYBREVANT FASPRO in combination with LAZCLUZE achieved a high objective response rate in previously untreated patients with EGFR-mutated advanced non-small cell lung cancer. The study also reported administration-related reactions of 12% with monthly dosing, compared with 13% for biweekly subcutaneous dosing and 66% with historical intravenous administration.
No new safety signals were identified, the company said. Eight percent of patients discontinued amivantamab due to treatment-related adverse events. Rates of venous thromboembolic events were comparable between monthly and biweekly subcutaneous dosing and lower than historical intravenous data without anticoagulation.
“A monthly dosing schedule offers patients convenience without sacrificing efficacy,” said Dr. Danny Nguyen, assistant clinical professor of medical oncology and therapeutics research at City of Hope and principal investigator for the PALOMA-3 and MARIPOSA studies.
Johnson & Johnson said the approval builds on prior FDA authorization in December 2025 for subcutaneous RYBREVANT FASPRO across all indications of intravenous RYBREVANT®.
The PALOMA-2 Phase 2 study evaluated first-line subcutaneous amivantamab combined with LAZCLUZE and/or chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer. The primary endpoint was objective response rate as assessed by investigators.
The Phase 3 MARIPOSA study, which enrolled 1,074 patients, is evaluating RYBREVANT plus LAZCLUZE versus osimertinib and LAZCLUZE alone in first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer. An analysis presented at the 2025 World Congress on Lung Cancer showed lower rates of MET amplification and secondary EGFR mutations with the combination compared with osimertinib, the company said.
Non-small cell lung cancer accounts for approximately 80% to 85% of all lung cancer cases worldwide. EGFR mutations occur in an estimated 10% to 15% of Western patients with adenocarcinoma histology and 40% to 50% of Asian patients, according to data cited by the company.
Johnson & Johnson said information about patient access and support programs is available at RYBREVANTwithMe.com or by calling 833-565-9631.
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