Darzalex Faspro Secures New First-Line Indication for Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant, Driving $14.35B Annual Sales

Local time on January 27, FDA Announces Approval of Daratumumab Subcutaneous Injection Formulation（Daratumumab + Hyaluronidase,Darzalex Faspro）Combined with bortezomib, lenalidomide, and dexamethasone（D-VRd）Used forNot Suitable for Autologous Stem Cell Transplantation（ASCT）Newly diagnosed adult patients with multiple myeloma。

D-VRd It is currently the only approved anti-CD38 antibody regimen for all newly diagnosed patients, regardless of whether they are eligible for transplantation.。

Source: FDA Official Website

This approval is based on an open-label, randomized, positive-controlled pivotal Phase IIICEPHEUS Study Data(Registration No.:NCT03652064）. A total of395 subjects, RandomGroup AcceptanceD-VRd（n=197）And VRd（n=198）Treatment. The primary endpoint is the Independent Review Committee.（IRC）Overall Minimal Residual Disease Assessment（MRD）Negative Rate and Progression-Free Survival（PFS）。

The results showed a median follow-up of 22 months,The MRD-negative rate in the D-VRd group was 52.3%., VRd group was 34.8%（p < 0.0005）。Median follow-up of 39 months,D-VRd GroupThe proportion of patients with sustained MRD negativity ≥12 months nearly doubled, increasing from 25.3% to 42.6%.( P < 0.0003), at the same timeCompared with the VRd regimen,Significantly reduced the risk of disease progression or death by 40%(HR 0.60; 95% CI 0.41-0.88;P < 0.0078）. Median follow-up was 59 months,The D-VRd group showed a significantly higher degree of relief, with a higher rate of complete response or better, increasing from 61.6% with VRd to 81.2%.

Overall survival data are not yet mature,The efficacy of the D-VRd regimen for patients who refuse ASCT as initial treatment has not been established. In terms of safety,The overall safety results of D-VRd are consistent withDarzalex Faspro, VRd are consistent.

Previously, in July 2024,D-VRd has been approved in the United States for newly diagnosed multiple myeloma suitable for ASCT.Myeloma patients. CurrentlyDarzalex Faspro has been approved for 12 indications, covering multiple myeloma,AL amyloidosis, etc., among whichFive Indications Approved for Newly Diagnosed Multiple Myeloma。

According to Johnson & Johnson's latest financial report,Daratumumab 2025 Full-Year Sales Reach $14.351 Billion, an increase of 23% over the same period last year.

Cover Source:Corporate Logo

Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.

Editor: Crescent

PR Article Coordination: WeChat insightxb