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:
“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.”2 EBOREFERENCES
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.
Lack of Mutations Associated With Favorable Prognosis in MPN-U
April 25th 2024While the Dynamic International Prognostic Scoring System and bone marrow blasts may predict overall survival, the lack of certain mutations is also associated with a better prognosis for myeloproliferative neoplasm, unclassifiable (MPN-U).
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
HOPE-CAT Can Identify Maternal Cardiovascular Risk 2 Months Earlier Than Doctors, Study Says
April 25th 2024In a retrospective study, the machine learning tool was able to screen for potential risks of cardiovascular disease nearly 60 days before the patient's medical record showed any signs of a related condition or before they were officially diagnosed or treated for it.
Read More
Data Back Neoadjuvant Combo vs Chemo Alone for Early-Stage NSCLC
April 24th 2024For patients with early-stage non–small cell lung cancer (NSCLC), combining neoadjuvant immune checkpoint inhibitors and platinum-based chemotherapy improves 2-year outcomes over chemotherapy alone, suggest findings of an extensive literature review and meta-analysis.
Read More