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

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.”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.

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