{"id":61862,"date":"2026-03-30T18:28:55","date_gmt":"2026-03-30T10:28:55","guid":{"rendered":"https:\/\/flcube.com\/?p=61862"},"modified":"2026-03-30T18:28:55","modified_gmt":"2026-03-30T10:28:55","slug":"jjs-darzalex-sc-becomes-first-oncology-injectable-in-europe-approved-for-patient-self-administration","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=61862","title":{"rendered":"J&J\u2019s Darzalex SC Becomes First Oncology Injectable in Europe Approved for Patient Self-Administration"},"content":{"rendered":"\n

Johnson & Johnson<\/strong> (J&J, NYSE: JNJ<\/a>) announced that the Committee for Medicinal Products for Human Use (CHMP)<\/strong> of the European Medicines Agency (EMA)<\/strong> has approved a Type II variation<\/strong> to the label of Darzalex\u00ae (daratumumab) subcutaneous (SC) formulation<\/strong>, enabling patients with multiple myeloma\u2014or their trained caregivers\u2014to self-administer the therapy starting from the fifth dose<\/strong>. This landmark decision makes Darzalex SC the first oncology injectable in Europe authorized for at-home self-use<\/strong>, marking a major advance in treatment convenience and patient autonomy for a chronic blood cancer requiring long-term therapy.<\/p>\n\n\n\n

Regulatory Update Summary<\/h2>\n\n\n\n
Approval Detail<\/th>Description<\/th><\/tr><\/thead>
Agency<\/strong><\/td>EMA CHMP<\/td><\/tr>
Product<\/strong><\/td>Darzalex (daratumumab) SC<\/td><\/tr>
Indication<\/strong><\/td>Multiple myeloma<\/td><\/tr>
New Authorization<\/strong><\/td>Self-administration from Dose 5 onward<\/strong><\/td><\/tr>
Conditions<\/strong><\/td>– Healthcare professional deems appropriate
– Patient\/caregiver completes proper training<\/td><\/tr>
Significance<\/strong><\/td>First oncology injectable in Europe approved for self-administration<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The change builds on Darzalex SC\u2019s existing approval as the only CD38-targeting antibody available in subcutaneous form<\/strong> for multiple myeloma.<\/p>\n\n\n\n

Technology Enabling Self-Administration<\/h2>\n\n\n\n