Tag Archives: daratumumab

December, 2018

5 December
Phase 3 Study of Darzalex Shows Efficacy and Safety in Patients with Newly Diagnosed Multiple Myeloma

BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 3 MAIA study demonstrating that the addition of daratumumab to lenalidomide and dexamethasone (Rd) significantly reduced the risk of disease progression or death in patients with newly diagnosed multiple myeloma who are ineligible for …
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30 October
Genmab Announces Positive Topline Results in Phase III Study of Daratumumab in Front Line Multiple Myeloma

Copenhagen, Denmark; October 29, 2018 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III MAIA study (MMY3008) of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus Rd alone as treatment for newly diagnosed patients who are not candidates for high dose chemotherapy and autologous stem …
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1 June
Halozyme Identifies Plasma Biomarkers as Potential Predictors of Survival in Pancreatic Cancer

SAN DIEGO, June 1, 2018 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, will present data evaluating certain biomarkers as potential predictors of survival in patients with previously untreated metastatic pancreatic ductal adenocarcinoma at the American Society of Clinical Oncology (ASCO) annual meeting, …
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9 May
FDA Approves Janssen’s Darzalex for Newly Diagnosed Multiple Myeloma Patients Who Are Transplant Ineligible

HORSHAM, PA, May 7, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) in combination with VELCADE® (bortezomib)*, a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone – VMP – for the treatment of patients with …
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13 December
Darzalex Combination Regimen Significantly Improved Outcomes for Multiple Myeloma Patients who are Transplant Ineligible

BEERSE, Belgium–(BUSINESS WIRE)–Janssen-Cilag International NV (“Janssen”) today announced data from the Phase 3 ALCYONE study, showing Darzalex® (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) significantly improved clinical outcomes, including reducing the risk of disease progression or death by 50 percent, in patients with newly diagnosed multiple myeloma who are …
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24 August
Genmab’s Daratumumab Meets Primary Endpoint in Late-Stage Multiple Myeloma Study

Copenhagen, Denmark; August 24, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III ALCYONE study (MMY3007) of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone as front line treatment for newly diagnosed patients who are not considered candidates for autologous stem …
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21 June
Janssen to Utilize Adaptive’s NGS-Based clonoSEQ Assay to Measure MRD in Darzalex Multiple Myeloma Trials

SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies, the leader in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announces it has partnered with Janssen Biotech, Inc. to utilize Adaptive’s NGS-based clonoSEQ Assay for measuring minimal residual disease (MRD) in patients with Multiple Myeloma …
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16 June
FDA Approves Darzalex in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

HORSHAM, Pa., June 16, 2017 /PRNewswire/ — Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy DARZALEX® (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide …
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30 March
Genmab Discontinues Mid-Stage Non-Hodgkin’s Lymphoma Study

Copenhagen, Denmark; March 30, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its collaboration partner for daratumumab, Janssen Biotech, Inc., has decided not to initiate stage 2 of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma (NHL). The study …
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22 November
Genmab Announces FDA Approval of Darzalex for Treatment of Multiple Myeloma

Copenhagen, Denmark; November 21, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today the U.S. Food and Drug Administration (FDA) has approved the use of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least …
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