{"id":57738,"date":"2026-02-24T18:02:09","date_gmt":"2026-02-24T10:02:09","guid":{"rendered":"https:\/\/flcube.com\/?p=57738"},"modified":"2026-02-24T18:02:10","modified_gmt":"2026-02-24T10:02:10","slug":"jjs-rybrevant-sc-dosing-approved-by-ec-expands-subcutaneous-options-across-all-nsclc-indications","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=57738","title":{"rendered":"J&J’s RYBREVANT SC Dosing Approved by EC \u2013 Expands Subcutaneous Options Across All NSCLC Indications"},"content":{"rendered":"\n

Johnson & Johnson (J&J, NYSE:\u202fJNJ<\/a>)<\/strong> announced that the European Commission (EC)<\/strong> has approved an extension of the RYBREVANT (amivantamab)<\/strong> marketing authorization to include additional subcutaneous (SC)<\/strong> dosing regimens. The approval enables SC amivantamab<\/strong> use across all previously approved intravenous (IV) indications<\/strong>, offering reduced administration time from hours to minutes while maintaining comparable efficacy and safety.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Johnson & Johnson (NYSE:\u202fJNJ)<\/td><\/tr>
Product<\/strong><\/td>RYBREVANT (amivantamab)<\/td><\/tr>
Regulatory Body<\/strong><\/td>European Commission (EC)<\/td><\/tr>
Approval Type<\/strong><\/td>Marketing authorization extension<\/td><\/tr>
New Administration Routes<\/strong><\/td>Subcutaneous (SC) dosing regimens<\/td><\/tr>
Formulation<\/strong><\/td>Co\u2011formulated with rHuPH20 (Halozyme ENHANZE technology)<\/td><\/tr>
Supporting Data<\/strong><\/td>Phase 2 PALOMA\u20112 and Phase 1 PALOMA studies<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Approved SC Dosing Regimens<\/h2>\n\n\n\n

Every\u2011Four\u2011Week (Q4W) SC Amivantamab<\/h3>\n\n\n\n
Indication<\/th>Patient Population<\/th><\/tr><\/thead>
Combination with LAZCLUZE (lazertinib)<\/strong><\/td>First\u2011line advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations<\/td><\/tr>
Monotherapy<\/strong><\/td>Advanced NSCLC with EGFR exon 20 insertion mutations after platinum\u2011based therapy failure<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Every\u2011Three\u2011Week (Q3W) SC Amivantamab + Chemotherapy<\/h3>\n\n\n\n
Indication<\/th>Patient Population<\/th><\/tr><\/thead>
Combination with carboplatin + pemetrexed<\/strong><\/td>Advanced NSCLC with EGFR exon 19 deletions or L858R mutations after prior EGFR TKI failure<\/td><\/tr>
Combination with carboplatin + pemetrexed<\/strong><\/td>Advanced NSCLC with EGFR exon 20 insertions as first\u2011line treatment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile \u2013 Amivantamab<\/h2>\n\n\n\n