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Biotechnology products and indications I. Proteins
Published in Ronald P. Evens, Biotechnology, 2020
Four interleukins are in use for renal cell carcinoma and malignant melanoma [interleukin-2 (IL-2)], cutaneous T-cell lymphoma (denileukin), thrombocytopenia associated with cancer chemotherapy (IL-11), and rheumatoid arthritis (IL-1ra, anakinra). These interleukins are protein products from rDNA manufacturing and physiologically are usually local intercellular communication molecules that, when used systemically as a therapeutic, can cause substantial multi-organ toxicity, especially cardiovascular, limiting their full clinical usefulness and characterizing most interleukins. Denileukin is a fusion protein of IL-2 and diphtheria toxin. Anakinra is a receptor antagonist to IL-1. Oprelvekin (IL-11) stimulates progenitor cells such as megakaryocytes to produce more platelets and reduce bleeding in several conditions.
Principal Side-Effects of the Treatment of Leukemias, Lymphomas, and Myelomas
Published in Tariq I Mughal, John M Goldman, Sabena T Mughal, Understanding Leukemias, Lymphomas, and Myelomas, 2017
Tariq I Mughal, John M Goldman, Sabena T Mughal
The first such drug to receive Food and Drug Administration (FDA) approval in November 1997 was interleukin-11 or oprelvekin (Neumega). It was approved for adult patients with non-myeloid cancers for chemotherapy-related thrombocytopenia based on studies confirming the drug’s efficacy in patients who had experienced severe thrombocytopenia following chemotherapy. In general the drug is indeed quite safe but in early 2009 there has been some concern about changes in visual acuity and visual field defects, possibly related to optic neuropathy, in addition to ventricular arrhythmias. Further tests are now in progress. The other two platelet-stimulating drugs are the subcutaneously administered romiplostim (AMG-531) and the orally administered eltrombopag (Promacta). Both drugs received regulatory approval by the FDA in 2008 for use in chronic immune thrombocytopenia and chemotherapy-induced thrombocytopenia.
Emerging data on thrombopoietin receptor agonists for management of chemotherapy-induced thrombocytopenia
Published in Expert Review of Hematology, 2023
Andrew B. Song, Hanny Al-Samkari
Recombinant human interleukin 11 (oprelvekin) is a thrombopoietic cytokine promoting megakaryocyte development that was previously approved by the US FDA for prevention and treatment of CIT. Although studies of oprelvekin produced data suggesting efficacy in raising platelet count and reducing about 30% of platelet transfusions [10], it was poorly tolerated in treated patients with notable toxicities of constitutional symptoms, fluid retention, dilutional anemia, and cardiac arrythmias. Pharmacoeconomic analysis showed that healthcare costs savings from reduction of platelet transfusions and associated transfusion reactions were greatly outweighed by the significant costs of oprelvekin (expected cost of $3,000–5,000 USD over a three week period in 2003) [11]. The financial impact and toxicities of oprelvekin outweighed the modest clinical efficacy, and oprelvekin was voluntarily withdrawn from the market by the manufacturer several years ago.
Clinical challenges and promising therapies for chemotherapy-induced thrombocytopenia
Published in Expert Review of Hematology, 2021
Hanny Al‐Samkari, Gerald A. Soff
Oprelvekin achieved U.S. FDA approval for the prevention of CIT in patients with non-myeloid malignancies following demonstration of modest efficacy to treat preexisting CIT and prevent CIT (essentially an absolute reduction in requirement for platelet transfusion of approximately 30% in two studies) [32]. Unfortunately, oprelvekin precipitated unwanted toxicities in a majority of treated patients, including fever, myalgia, edema, dilutional anemia and atrial arrhythmias. Additionally, it was expensive, with a 2003 pharmacoeconomic analysis finding the cost of oprelvekin use to exceed 5000 USD for a single treatment cycle, over 50% higher than the cost of platelet transfusion [33]. The modest efficacy, considerable toxicities, and cost precluded widespread uptake of oprelvekin in oncology care, and the drug was discontinued by the manufacturer in the U.S.