daratumumab

New Clinical and Real-World Data Support Use of DARZALEX®▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma

Retrieved on: 
Saturday, December 11, 2021
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Survival, Dexamethasone, MRD, Clinical trial, Lymphatic system, ASH, Patient, Abstract, Lenalidomide, Physician, EMEA, Janssen Pharmaceuticals, VRD, Minimal, Multiple myeloma, Bortezomib, Highlight, SCR, Society, Johnson & Johnson, Pharmaceutical industry, the GRIFFIN Study1,6, the MAIA Study7, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson, THE GRIFFIN STUDY1,6, THE MAIA STUDY7, DARATUMUMAB, MULTIPLE MYELOMA, THE JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON

The clinical data presented at ASH support daratumumab as a foundational therapy for patients with newly diagnosed multiple myeloma in transplant-ineligible populations, said Imran Khan, M.D., Ph.D., U.S. Vice President, Medical Affairs, Hematology, Janssen Scientific Affairs, LLC.

Key Points: 
  • The clinical data presented at ASH support daratumumab as a foundational therapy for patients with newly diagnosed multiple myeloma in transplant-ineligible populations, said Imran Khan, M.D., Ph.D., U.S. Vice President, Medical Affairs, Hematology, Janssen Scientific Affairs, LLC.
  • Real-world evidence about efficacy, safety and adherence is becoming increasingly important for clinicians in optimising treatment approaches for patients with multiple myeloma.
  • Janssen is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.
  • Real-World Patient Characteristics and Treatment Outcomes Among Newly Diagnosed Multiple Myeloma Patients Initiating Daratumumab, Lenalidomide, and Dexamethasone As First-Line Therapy.

 Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX®▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible

Retrieved on: 
Saturday, June 12, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Drugs, Health care, Health sciences, Orphan drugs, Daratumumab, Multiple myeloma, Lenalidomide, Bortezomib, Dexamethasone, Janssen Pharmaceuticals, Cilag, Immunomodulatory imide drug, the MAIA Trial, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson, THE MAIA TRIAL, DARATUMUMAB, MULTIPLE MYELOMA, THE JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON

These results strongly support the use of daratumumab, lenalidomide and dexamethasone as a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma.

Key Points: 
  • These results strongly support the use of daratumumab, lenalidomide and dexamethasone as a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma.
  • Janssen Research & Development, LLC, Janssen-Cilag Ltd., Janssen Pharmaceutica NV and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Overall Survival Results With Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

European Commission Grants Marketing Authorisation for DARZALEX®▼(daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications

Retrieved on: 
Thursday, June 4, 2020
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Drugs, Medicine, Clinical medicine, Orphan drugs, Monoclonal antibodies, RTT, Breakthrough therapy, Daratumumab, Lenalidomide, Multiple myeloma, Dexamethasone, Isatuximab, the COLUMBA Study (MMY3012)6,7, the PLEIADES Study (MMY2040)8, daratumumab, Multiple Myeloma (MM), the Janssen Pharmaceutical Companies of Johnson & Johnson

The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.

Key Points: 
  • The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.
  • Patients with relapsed or refractory disease were treated with 1,800 mg of daratumumab SC plus lenalidomide and dexamethasone (D-Rd).
  • Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial.
  • A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma.

European Commission Approves Darzalex®▼ (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Retrieved on: 
Monday, January 20, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Drugs, Medicine, Clinical medicine, Orphan drugs, Monoclonal antibodies, Cancer treatments, RTT, Immunosuppressants, Daratumumab, Multiple myeloma, Bortezomib, Thalidomide, the CASSIOPEIA Trial, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson

We are thrilled that newly diagnosed patients with multiple myeloma and their doctors will have a long-awaited additional frontline therapy.

Key Points: 
  • We are thrilled that newly diagnosed patients with multiple myeloma and their doctors will have a long-awaited additional frontline therapy.
  • The study included 1,085 newly diagnosed patients with previously untreated, symptomatic multiple myeloma who were eligible for high-dose chemotherapy and stem cell transplant.
  • Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results.
  • Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study.

CHMP Grants Positive Opinion for Expanded Use of Darzalex®▼ (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Retrieved on: 
Friday, December 13, 2019
Oncology, Health, Stem cells, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Medicine, Health, Orphan drugs, Cancer treatments, Monoclonal antibodies, Immunosuppressants, Teratogens, Daratumumab, Multiple myeloma, Bortezomib, Johnson & Johnson, the CASSIOPEIA Trial, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson

The study included 1,085 newly diagnosed patients with previously untreated, symptomatic multiple myeloma who were eligible for high-dose chemotherapy and stem cell transplant.

Key Points: 
  • The study included 1,085 newly diagnosed patients with previously untreated, symptomatic multiple myeloma who were eligible for high-dose chemotherapy and stem cell transplant.
  • Janssen-Cilag, Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Darzalex®▼ (daratumumab) Regimen Shows Significant Increase in Progression-Free Survival in Treatment of Patients with Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Tuesday, December 10, 2019
Oncology, Health, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Orphan drugs, Clinical medicine, Medicine, Monoclonal antibodies, Cancer treatments, Breakthrough therapy, Daratumumab, Pyrazines, Multiple myeloma, Bortezomib, Isatuximab, the CANDOR study, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson

This Phase 3 study adds to the body of evidence related to the use of daratumumab in combination with established regimens for the treatment of patients with relapsed multiple myeloma.

Key Points: 
  • This Phase 3 study adds to the body of evidence related to the use of daratumumab in combination with established regimens for the treatment of patients with relapsed multiple myeloma.
  • We are committed to the continued study of daratumumab as a treatment in patients with multiple myeloma.
  • This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the benefits of daratumumab for the treatment of patients with multiple myeloma.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Darzalex®▼ (daratumumab) Shows Overall Survival Benefit and Continued Improvement in Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who are Ineligible for Transplant

Retrieved on: 
Monday, December 9, 2019
Oncology, Health, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Medicine, Health, Orphan drugs, Monoclonal antibodies, Immunosuppressants, RTT, Breakthrough therapy, Daratumumab, Lenalidomide, Multiple myeloma, Bortezomib, the ALCYONE study (NCT02195479)4, the MAIA study (NCT02252172)5, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson

Cilag GmbH International; Janssen Biotech, Inc. and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points: 
  • Cilag GmbH International; Janssen Biotech, Inc. and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • 1 Maria-Victoria Mateos et al.Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Patients With Transplant-ineligible Newly Diagnosed Multiple Myeloma: Overall Survival in ALCYONE.
  • Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant: Updated Analysis of MAIA.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Janssen Receives EU Marketing Authorisation for Darzalex®▼(daratumumab) in Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible

Retrieved on: 
Tuesday, November 19, 2019
Biotechnology, Pharmaceutical, Health, Oncology, Drugs, Medicine, Clinical medicine, Orphan drugs, Monoclonal antibodies, RTT, Immunosuppressants, Aromatic amines, Daratumumab, Lenalidomide, Multiple myeloma, Dexamethasone, the MAIA (NCT02252172) Trial5, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson

Janssen-Cilag, Janssen Biotech, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points: 
  • Janssen-Cilag, Janssen Biotech, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA).
  • Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma.
  • A study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma.

Janssen Seeks EMA Approval for Novel Subcutaneous Formulation of DARZALEX®▼ (daratumumab)

Retrieved on: 
Friday, July 19, 2019
Research, Clinical trials, Biotechnology, Pharmaceutical, Health, Oncology, Science, the COLUMBA Trial (NCT03277105)4, the PLEIADES Trial (MMY2040)2, daratumumab, Multiple Myeloma, the Janssen Pharmaceutical Companies of Johnson & Johnson

This subcutaneous formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's ENHANZE drug delivery technology].

Key Points: 
  • This subcutaneous formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's ENHANZE drug delivery technology].
  • Janssen has also submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the new daratumumab subcutaneous formulation.
  • Patients with relapsed or refractory disease were treated with 1,800 mg of the subcutaneous formulation plus lenalidomide and dexamethasone (D-Rd).
  • Janssen-Cilag, Janssen Biotech, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.