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Daratumumab Approval Yields the First Monoclonal Antibody, and Another Option, in Multiple Myeloma
The drug was approved based on results of 2 open-label studies that showed reduction in tumor burden of patients who had previously received multiple lines of therapy.
The FDA today approved daratumumab for patients with multiple myeloma who have previously been treated with at least 3 regimens. Daratumumab, which received breakthrough status 2 years back, is the first monoclonal antibody approved for multiple myeloma.
The approval follows review of 2 open-label studies that included 106 and 42 participants. The first study (phase 2 MMY2002) saw 29% of patients with a complete or partial reduction in tumor burden that was sustained for at least 7.4 months. These patients had received a median of 5 lines of prior therapy. The second study (phase 1/2 GEN501) saw a complete or partial reduction in tumor burden of 36% of patients. These patients had received a median of 4 lines of prior therapy. Today’s approval is the first for a CD38 antibody and comes just 2 months after the drug was submitted for priority review.
Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, hailed daratumumab as another option for patients to turn to when their disease has developed resistance to all other existing therapies.
Some of the side-effects associated with the drug include infusion-related reactions, fatigue, nausea, back pain, fever, and cough. Daratumumab may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia), and low levels of blood platelets (thrombocytopenia).
Daratumumab, approved under the FDA’s accelerated approval program, had an orphan drug designation.
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
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Government agencies have created an online portal for the public to report potential anticompetitive practices in health care; there are changes coming to the “boxed warning” section for chimeric antigen receptor T-cell therapies (CAR T) to highlight T-cell blood cancer risk; questions about the safety of obesity medications during pregnancy have arisen in women on them who previously struggled with fertility issues.
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Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
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Pegcetacoplan for PNH More Cost-Effective Than Anti-C5 Monoclonal Antibodies
April 18th 2024A cost-utility analysis conducted from the perspective of the Italian health system found that pegcetacoplan was more effective and less costly than 2 complement 5 (C5) inhibitors for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
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