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FDA Grants Breakthrough Therapy Designation for Daratumumab in Combination With Standard of Care for Multiple Myeloma

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the immunotherapy daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy, Janssen Research & Development, LLC, announced. This marks the second time daratumumab has received a Breakthrough Therapy Designation, which is intended to expedite the development and review timelines of potential new medicines to treat serious or life-threatening diseases, where preliminary clinical evidence shows that the medicine may provide substantial improvement over existing therapies.

“Despite tremendous progress in the past 15 years, multiple myeloma remains a highly complex and difficult disease to treat, with most patients relapsing or becoming resistant to therapy,” said MMY3003 (POLLUX) lead study author Meletios A. Dimopoulos, MD, Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Alexandra General Hospital, Athens, Greece. “Daratumumab has already shown pronounced activity as a monotherapy in heavily pretreated patients. This designation underscores the potential of daratumumab in combination with either a proteasome inhibitor or an immunomodulatory agent to provide much-needed benefit to patients with at least one prior therapy.”

Breakthrough Therapy Designation was granted to daratumumab based on data from two phase III studies:

  • The MMY3004 (CASTOR) clinical trial evaluating daratumumab in combination with bortezomib and dexamethasone, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received at least one prior therapy. Overall, the daratumumab combination therapy demonstrated a reduction in the risk of disease progression or death. These results were also presented by Palumbo et al at the 2016 ASCO Annual Meeting (Abstract LBA4).
  • The MMY3003 (POLLUX) clinical trial evaluating daratumumab in combination with lenalidomide and dexamethasone, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received at least one prior therapy. Overall, the addition of daratumumab reduced the risk of disease progression or death in these patients. These results were presented by Dimopoulos et al at the 21st Annual Congress of the European Hematology Association in June 2016 (Abstract LB2238).

“We are pleased that the FDA has granted a second Breakthrough Therapy Designation to daratumumab. 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,” said Craig L. Tendler, MD, Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology, and Supportive Care, Janssen Research & Development, LLC. “We look forward to working closely with the FDA throughout the review process and remain committed to exploring the full clinical benefit of this promising compound for multiple myeloma patients who are eagerly awaiting new treatment options.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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