On May 14, the CDE website showed that Johnson & JohnsonDaratumumab Injection(Subcutaneous injection)New indications for marketing application have been accepted. The registration classification of this product application is3.1 ClassThat is, the application for marketing of biologics produced overseas that have been marketed overseas but not yet in China.Based on publicly available information and clinical progress, the Insight database infers that the indication for this marketing application is:Combination of Bortezomib, Lenalidomide, and Dexamethasone（VRd）, for newly diagnosed multiple myeloma patients suitable for hematopoietic stem cell transplantation.
Screenshot source: CDE official websiteDaratumumab isThe World's First Approved CD38 Monoclonal Antibody, November 2015, DareDaratumumab Receives First FDA Approval for Marketing, in Combination with Lenalidomide and Dexamethasone, or Bortezomib and Dexamethasone, for the Treatment of Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy.First conditionally approved for marketing in China in July 2019, as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma.Daratumumab has always been a core product in Johnson & Johnson's oncology business, and its performance has continued to grow since its initial approval, with global sales reaching$11.67 billion, representing a year-on-year increase of 19.77%. This is since the drug's launch in 2015,First Annual Sales Breakthrough of $10 Billion。Johnson & Johnson has developed a subcutaneous injection formulation of this drug containing daratumumab and recombinant human hyaluronidase PH20.（rHuPH20）Comprising a fixed-dose combination, the subcutaneous injection was first approved by the FDA for marketing in May 2020 and has been available since.8 ItemsIndications approved. In China, it was first approved in October 2021 and has been approved so far.7 itemsIndications.PERSEUS is aA Phase III Study in Patients with Previously Untreated Multiple Myeloma to Compare Daratumumab, VELCADE(Bortezomib), Lenalidomide and Dexamethasone（D-VRd）WithEfficacy of VRd.The primary endpoint of the study is PFS.。At the 2023 ASH Conference, Johnson & Johnson presented the primary analysis results of the trial. In the trial, 709 patients were randomly assigned to groups.（D-VRd group, n=355; VRd group, n=354), 314 patients in the D-VRd group and 299 patients in the VRd group have completed all four induction treatment cycles and two consolidation treatment cycles, with 309 and 294 patients respectively receiving autologous stem cell transplantation.（ASCT）, with 322 and 300 patients entering the maintenance treatment phase, respectively.
The median follow-up time was 47.5 months in the D-VRd group.PFS significantly outperformed the VRd group（HR，0.42）. The median PFS was not reached in either group; the D-VRd groupThe 48-month PFS rate was 84.3%., VRd group was 67.7%. D-VRd group'sCR（87.9% vs 70.1%；P < 0.0001）and MRD negativity rate（75.2% vs 47.5%；P < 0.0001）Significantly higher than the VRd group. Overall survival rate is not yet mature.
In terms of safety, there were 78 deaths in the study.(D-VRd, 34 cases; VRd, 44 cases). Overall, there were 7 deaths from COVID-19.(D-VRd, 4 cases; VRd, 3 cases)D-VRd/VRd group was the most common（≥10%）Grade 3/4 adverse events occurring during treatment（TEAE）Including neutropenia, thrombocytopenia, diarrhea, pneumonia, and febrile neutropenia. The incidence of severe TEAEs in the D-VRd group and VRd group was 57.0% and 49.3%, respectively, and the incidence of TEAEs leading to treatment discontinuation was 8.8% and 21.3%, respectively.
Screenshot source: Insight databaseCover Source:Company LogoDisclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If necessary, please consult and contact正规医疗机构.PR Article Coordination: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
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