{"id":56517,"date":"2026-02-06T21:26:14","date_gmt":"2026-02-06T13:26:14","guid":{"rendered":"https:\/\/flcube.com\/?p=56517"},"modified":"2026-02-06T21:26:16","modified_gmt":"2026-02-06T13:26:16","slug":"jj-darzalex-faspro-gets-nmpa-approval-for-transplant-eligible-myeloma-patients","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56517","title":{"rendered":"J&J Darzalex Faspro Gets NMPA Approval for Transplant-Eligible Myeloma Patients"},"content":{"rendered":"\n

Johnson & Johnson<\/strong> (J&J, NYSE:\u202fJNJ<\/a>) announced that Darzalex Faspro (daratumumab and hyaluronidase-fihj)<\/strong> has received National Medical Products Administration (NMPA)<\/strong> approval for an expanded indication in newly diagnosed multiple myeloma (MM)<\/strong>. The CD38-directed antibody<\/strong> is now indicated in combination with bortezomib, lenalidomide, and dexamethasone<\/strong> for adult patients eligible for autologous stem cell transplantation<\/strong>, marking its 11th MM indication<\/strong> globally.<\/p>\n\n\n\n

Regulatory Milestone & Drug Profile<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Johnson & Johnson (Janssen)<\/td><\/tr>
Drug<\/strong><\/td>Darzalex Faspro (daratumumab + hyaluronidase-fihj)<\/td><\/tr>
Mechanism<\/strong><\/td>CD38-directed monoclonal antibody<\/td><\/tr>
New Indication<\/strong><\/td>Newly diagnosed MM (transplant-eligible) in combination with VRd<\/td><\/tr>
Combination<\/strong><\/td>Bortezomib, lenalidomide, dexamethasone (VRd)<\/td><\/tr>
Approval<\/strong><\/td>NMPA expanded indication<\/td><\/tr>
Global Approvals<\/strong><\/td>11 MM indications (5 first-line)<\/td><\/tr>
First US Approval<\/strong><\/td>May 2020<\/td><\/tr>
Technology<\/strong><\/td>Halozyme ENHANZE\u00ae drug delivery (subcutaneous)<\/td><\/tr>
Strategic Significance<\/strong><\/td>Only subcutaneous anti-CD38 mAb approved for MM<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Licensing History & Market Position<\/h2>\n\n\n\n