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The 57th American Society of Hematology (ASH) Annual Meeting & Exposition

Abundant Optimism at the ASH/FDA Joint Symposium on New Drug Approvals in Multiple Myeloma

Surabhi Dangi-Garimella, PhD
Primary clinical reviewers from the FDA and 2 clinician experts provided their unique perspectives on the safety, efficacy, and potential for clinical integration of 3 recently approved agents for multiple myeloma: daratumumab (Darzalex), ixazomib (Ninlaro), and elotuzumab (Empliciti).
“We have witnessed unprecedented progress in the treatment of multiple myeloma (MM). Things have moved very well and most of this is because we now have a plethora of new drugs to support care pathways.” These opening statements by S. Vincent Rajkumar, MD, from the Mayo Clinic in Rochester, Minneapolis, summarized the objectives of a novel FDA-sponsored session at the end of the third day of the American Society of Hematology (ASH)’s annual meeting.

Primary clinical reviewers from the FDA who reviewed the applications for daratumumab (Darzalex), ixazomib (Ninlaro), and elotuzumab (Empliciti)—all approved in November 2015—discussed the safety and efficacy issues from the products' clinical trials and toxicity studies. Additionally, 2 clinician experts who have extensive experience with these drugs in clinical practice, discussed their perspectives on use of these products in the real-world setting, focusing on combination therapies and sequencing.

The session was moderated by Albert B. Deisseroth, MD, PhD, Office of Hematology and Oncology Products, FDA. “We are in the midst of a revolution in targeted drug therapies,” Deisseroth said. “Three new treatments of multiple myeloma were approved in just the past 3 weeks. To ensure that promising new products meet an unmet medical need, and are approved expeditiously, the FDA has introduced accelerated, fast track, breakthrough, and priority approvals.” Deisseroth pointed out that just in the last 3 years, 18 fast-track products were approved.

FDA Perspective


Barry W. Miller, MSN, CRNP, from the Office of Hematology and Oncology Products, FDA, introduced daratumumab, a human CD38-directed monoclonal antibody that received breakthrough therapy designation in May 2013 and accelerated approval on November 16, 2015. Miller was the primary clinical reviewer of the application.

“Daratumumab has been approved for the treatment of MM in patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent, or those who are double refractory to a PI and an immunomodulatory agent,” Miller said.

Miller showed that results from the MMY2002 trial were submitted for review. Daratumumab, he said, achieved its primary objective of overall response rate when used in 106 patients who had received a median of 5 prior therapies. About 80% of these patients had received autologous stem cell transplant. The duration of response, he showed, was 7.4 months.

“Daratumumab can, however, interfere with the determination of stringent and complete response,” Miller said, adding that a few adverse events (AEs) associated with the drug include infusion reaction, fatigue, and nausea. “To avoid these reactions, patients could be pre-medicated with an antipyretic or a corticosteroid and monitored,” he said.

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