Hyaluronidase

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma

Retrieved on: 
Tuesday, December 12, 2023

SAN DIEGO, Dec. 12, 2023 /PRNewswire/ -- Johnson & Johnson announced today the first data from the Phase 3 PERSEUS study highlighting significant clinical improvement with a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet induction, consolidation regimen and doublet maintenance regimen in the treatment of transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM). The data, showing an unrivaled progression-free survival (PFS) in a Phase 3 study evaluating TE NDMM and clinically significant improvement of rates of overall complete response (CR) or better and minimal residual disease (MRD) negativity over the comparator arm, were featured as a late-breaking oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting (Abstract #LBA-1). The data were published simultaneously in The New England Journal of Medicine.

Key Points: 
  • The data were published simultaneously in The New England Journal of Medicine .
  • Overall MRD negativity rates (10–5) were higher with D-VRd vs VRd (75.2 percent vs 47.5 percent; P
  • Overall survival (OS) data are not yet mature but trending favorably for the D-VRd arm compared to VRd.
  • "We will continue to advance innovative regimens and approaches with DARZALEX to deliver on our commitment of transforming outcomes for patients with multiple myeloma."

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2023

Retrieved on: 
Tuesday, October 17, 2023

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)
    COPENHAGEN, Denmark; October 17, 2023 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX® (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by Johnson & Johnson were USD 2,499 million in the third quarter of 2023.
  • Net trade sales were USD 1,369 million in the U.S. and USD 1,130 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Second Quarter of 2023

Retrieved on: 
Thursday, July 20, 2023

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)
    COPENHAGEN, Denmark; July 20, 2023 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX® (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by Johnson & Johnson were USD 2,431 million in the second quarter of 2023.
  • Net trade sales were USD 1,322 million in the U.S. and USD 1,110 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma

Retrieved on: 
Saturday, June 3, 2023

CHICAGO, June 3, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1 Data from the MonumenTAL-1 study highlight safety and efficacy results (Abstract #8036) and an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab (Abstract #8020).1,2 These data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 Additional data from the Phase 2 TRiMM-2 study, evaluating talquetamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), were presented (Abstract #8003) at the meeting.3

Key Points: 
  • CHICAGO, June 3, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1 Data from the MonumenTAL-1 study highlight safety and efficacy results ( Abstract #8036 ) and an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab ( Abstract #8020 ).1,2 These data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 Additional data from the Phase 2 TRiMM-2 study, evaluating talquetamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), were presented ( Abstract #8003 ) at the meeting.3
    Patients in the Phase 1/2 MonumenTAL-1 study (n=339) were treated with subcutaneous (SC) talquetamab at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) or 0.4 mg/kg weekly (QW) with step-up doses.1 The overall response rate (ORR) to talquetamab was similar across both doses.1 With a median follow-up of 12.7 months, 71.7 percent (104/145) of response-evaluable patients treated with the 0.8 mg/kg Q2W dose achieved a response, 60.7 percent achieved a very good partial response (VGPR) or better, nine percent achieved a complete response (CR), and 29.7 percent achieved a stringent complete response.1 With a median follow-up of 18.8 months, 74.1 percent (106/143) of response-evaluable patients treated with the 0.4 mg/kg QW dose achieved a response, 59.4 percent achieved a VGPR or better, 9.8 percent achieved a CR, and 23.8 percent achieved a stringent CR.1 In a separate cohort of patients treated with prior T-cell redirection therapy, 64.7 percent (33/51) achieved a response, and 54.9 percent achieved a VGPR or better, with a median follow-up of 14.8 months.1
    "The updated results from the MonumenTAL-1 study continue to show the encouraging potential of talquetamab for heavily pretreated patients with multiple myeloma, including those who may have been exposed to prior T-cell redirection therapy," said Carolina Schinke, M.D., Associate Professor of Medicine at the Myeloma Center at the University of Arkansas for Medical Sciences and principal investigator.† "With a high overall response rate among relapsed or refractory patients, the results underscore the efficacy of talquetamab as a novel option for later-line patients who otherwise face a poor prognosis, including patients with high-risk disease."
  • The safety profile was clinically manageable with low rates of Grade 3/4 infections (0.8 mg/kg Q2W dose, 25.5 percent; 0.4 mg/kg QW dose, 21.4 percent) and talquetamab discontinuations (1.5 percent).3 Almost all patients (95.4 percent) received antibacterial, antifungal or antiviral prophylaxis.
  • No new safety signals were observed with longer term follow-up.3 The most common non-hematologic AEs at the 0.8 mg/kg Q2W dose and 0.4 mg/kg QW dose cohorts were CRS (80 percent and 71 percent, respectively; all Grade 1/2), skin-related AEs (84 percent and 71 percent, respectively; Grade 3/4: eight percent and 14 percent, respectively) and nail-related AEs (69 percent and 57 percent, respectively; Grade 3/4: two percent and zero percent, respectively).3
    "The updated findings from MonumenTAL-1 and data from the TRiMM-2 study are exciting, as they demonstrate the continued promise of T-cell redirecting therapies as single agents or in combination with standard-setting treatments in multiple myeloma," said Chris Heuck, M.D., Global Medical Head, Oncology, Janssen Research & Development, LLC.
  • "At Janssen, we recognize that the future of multiple myeloma treatment lies in harnessing the power of combination therapies to target this complex disease, and the talquetamab results seen to date offer new hope to patients in need of additional treatment options."

Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2023

Retrieved on: 
Tuesday, April 18, 2023

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)
    COPENHAGEN, Denmark; April 18, 2023 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX® (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by Johnson & Johnson were USD 2,264 million in the first quarter of 2023.
  • Net trade sales were USD 1,191 million in the U.S. and USD 1,072 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for 2022

Retrieved on: 
Tuesday, January 24, 2023

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)
    COPENHAGEN, Denmark; January 24, 2023 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX® (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.), as reported by Johnson & Johnson were USD 7,977 million in 2022.
  • Net trade sales were USD 4,210 million in the U.S. and USD 3,767 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for the Third Quarter of 2022

Retrieved on: 
Tuesday, October 18, 2022

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)
    COPENHAGEN, Denmark; October 18, 2022 Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 2,052 million in the third quarter of 2022.
  • Net trade sales were USD 1,097 million in the U.S. and USD 955 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.
  • Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for the Second Quarter of 2022

Retrieved on: 
Tuesday, July 19, 2022

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen)
    COPENHAGEN, Denmark; July 19, 2022 Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,986 million in the second quarter of 2022.
  • Net trade sales were USD 1,021 million in the U.S. and USD 965 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.
  • Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer.

Breast Cancer Monoclonal Antibodies Global Market Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Monday, June 20, 2022

The "Breast Cancer Monoclonal Antibodies Global Market Report 2022: By Product, By End-User" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Breast Cancer Monoclonal Antibodies Global Market Report 2022: By Product, By End-User" report has been added to ResearchAndMarkets.com's offering.
  • The breast cancer monoclonal antibodies (mAbs) market consists of sales of monoclonal antibodies by entities (organizations, sole traders and partnerships) that produce breast cancer monoclonal antibodies used as therapy for breast cancer either as monotherapy or combination therapy.
  • The companies engaged in the breast cancer monoclonal antibodies market are primarily focused on the research, development, and production of monoclonal antibodies that are used in early-stage and advanced breast cancer, ductal carcinoma in-situ, triple-negative breast cancer, inflammatory breast cancer, and others.
  • Global Breast Cancer Monoclonal Antibodies Market, Segmentation By Product, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
    6.2.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2022

Retrieved on: 
Tuesday, April 19, 2022

Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc.

Key Points: 
  • Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc.
    COPENHAGEN, Denmark; April 19, 2022 Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,856 million in the first quarter of 2022.
  • Net trade sales were USD 953 million in the U.S. and USD 903 million in the rest of the world.
  • Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab.
  • Genmab has the right to seek review of the award, which it must do within a limited period of time.