Currently Viewing:
Evidence-Based Oncology August 2016
Solutions for Reducing Patient Cost Sharing for Medications
Marialanna Lee, MSC; Brian Connell; Elisa Weiss, PhD; and Louis J. DeGennaro, PhD
Charitable Assistance Among Economically Vulnerable Cancer Patients: Patient Access Network Foundation Summary Statistics 2011-2015
Helaine E. Resnick PhD, MPH; Bruce Barth; and Daniel Klein, MHS
The Toll of Cancer Care - Clinical and Financial Toxicity
Joseph Alvarnas, MD
Does the Cost-Sharing Burden Influence Cancer Outcomes?
Surabhi Dangi-Garimella, PhD
Improve Medicare Policy to Remove Barriers to Bone Marrow and Cord Blood Transplants
Jeffrey W. Chell, MD
Proton Therapy Eliminates Unnecessary Radiation Exposure and Is Medically Necessary
Steven J. Frank, MD
Finding Solutions for Cancer Patients: The American Cancer Society's Health Insurance Assistance Service
Katherine Sharpe, MTS; Melissa Fellers; Mandi Battaglia Seiler
Precision Oncology: Why Payers Should Initiate CGP Coverage Now!
Jerry Conway and Ingrid Marino, MS, CGC
Young Adult Cancer Survivors Disproportionately Affected by Treatment Costs
Samantha Watson, MBA, and Michelle Landwehr, MPH
Patient Access to Reference Pricing Prompts Choice of Lower-Cost Testing Laboratories, Cost Savings
Surabhi Dangi-Garimella, PhD
California Experiment Will Let Pathologists Report Cancer Diagnoses in Real Time
Surabhi Dangi-Garimella, PhD
Currently Reading
Breakthrough for Daratumumab for Use as Second-Line Treatment With Standard of Care in Multiple Myeloma
Surabhi Dangi-Garimella, PhD
Nivolumab Passes QOL Test in Melanoma
Surabhi Dangi-Garimella, PhD
The Risk of T2D in Individuals With Benign Adrenal Tumors
Surabhi Dangi-Garimella, PhD
Paying to Make Health IT Meaningful: A Discussion at the NCCN Policy Summit
Surabhi Dangi-Garimella, PhD
Health IT Essential for the Success of Cancer Moonshot
Surabhi Dangi-Garimella, PhD
Dissolving Data Silos and Improving Access to Health IT Essential in Oncology Care
Surabhi Dangi-Garimella, PhD

Breakthrough for Daratumumab for Use as Second-Line Treatment With Standard of Care in Multiple Myeloma

Surabhi Dangi-Garimella, PhD
The monoclonal antibody daratumumab (Darzalex) has been granted Breakthrough designation, the second for this drug, for use in combination with either lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy.
The monoclonal antibody daratumumab (Darzalex) has been granted Breakthrough designation, the second for this drug, for use in combination with either lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy.1 The drug was first approved in November 2015 in heavily pretreated patients diagnosed with multiple myeloma.

The new breakthrough status was based on the results of 2 pivotal phase 3 studies, both finding that including daratumumab reduced the risk of disease progression, as well as death, in patients with multiple myeloma:
  • MMY3004 (CASTOR) trial, which evaluated daratumumab in combination with the immunomodulatory agent dexamethasone and the proteasomal inhibitor bortezomib compared with bortezomib and dexamethasone alone, in patients who had received just a single prior line of therapy.
  • MMY3003 (POLLUX) trial, which evaluated daratumumab in combination with dexamethasone and the immunomodulatory agent lenalidomide compared with dexamethasone and lenalidomide alone, in patients who had received just a single prior line of therapy
“This is the second time daratumumab has earned the distinction of a Breakthrough Therapy designation. We are pleased that the FDA continues to recognize the potential of daratumumab to help patients with multiple myeloma. We continue to work with our strategic partner Janssen and the regulatory authorities to advance daratumumab to bring this treatment to more patients suffering from multiple myeloma as quickly as possible,” said Jan van de Winkel, PhD, chief executive officer of Genmab, which is developing the drug in collaboration with Janssen Research and Development.1

Craig L. Tendler, MD, vice president, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care, Janssen, said, “This is an important recognition of the transformative potential of daratumumab and its possible benefit as a backbone therapy in combination with two of the most widely used regimens for multiple myeloma.”EBO
REFERENCES
1. Daratumumab receives breakthrough therapy designation from US Food and Drug Administration in combination with standard of care regimens for previously treated multiple myeloma [press release]. Copenhagen, Denmark: Genmab A/S; July 25, 2016. https://globenewswire.com/news-release/2016/07/26/858766/0/en/Daratumumab-Receives-Breakthrough-Therapy-Designation-from-U-S-Food-and-Drug-Administration-in-Combination-with-Standard-of-Care-Regimens-for-Previously-Treated-Multiple-Myeloma.html.

2. Daratumumab (DARZALEX) granted breakthrough therapy designation by US Food and Drug Administration (FDA) for use in combination with standard of care regimens for patients with multiple myeloma [press release]. Raritan, NJ: StreetInsider.com; July 25, 2016. http://www.streetinsider.com/Press+Releases/Daratumumab+%28DARZALEX%C2%AE%29+Granted+Breakthrough+Therapy+Designation+by+U.S.+Food+and+Drug+Administration+%28FDA%29+for+Use+in+Combination+with+Standard+of+Care+Regimens+for+Patients+with+Multiple+Myeloma/11860903.html.
PDF
 
Copyright AJMC 2006-2017 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up
×

Sign In

Not a member? Sign up now!