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Drug That Increases Platelet Production Wins FDA Approval

Drug That Increases Platelet Production Wins FDA Approval

Genetics Institute, Inc., a subsidiary of American Home Products Corporation, has received FDA approval to market oprelvekin (recombinant interleukin-11 [Neumega]), a platelet growth factor that stimulates the production of blood platelets in cancer patients with solid tumors or lymphoma who are undergoing chemotherapy. Oprelvekin will be used to prevent severe thrombocytopenia and reduce the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of developing severe thrombocytopenia.

By significantly reducing the incidence of severely low platelet levels, which often delay chemotherapy, oprelvekin may give some cancer patients a better chance of receiving necessary treatment.

Results of Clinical Trials

In clinical trials involving 170 patients, oprelvekin reduced the incidence of severe chemotherapy-induced platelet depletion, decreased the need for platelet transfusions, and lowered the number of platelet transfusions required. By decreasing the proportion of patients who require platelet transfusions, use of oprelvekin may reduce the incidence of complications associated with platelet transfusions.

“For many patients with cancer, chemotherapy is the patient’s best option for treatment....Decreasing or delaying chemotherapy to allow blood-cell recovery can impact a patient’s treatment plan,” said Michael S. Gordon, md, associate professor of medicine and director of the Clinical Hematology and Cytokine Program at Indiana University Medical Center, Indianapolis. “Neumega may give patients at risk for severe thrombocytopenia a better chance for optimal treatment by enabling physicians to administer planned chemotherapy,” he added.

In clinical trials, the most common adverse events associated with oprelvekin included peripheral edema, dyspnea, tachycardia, and conjunctival redness. Most of these events were mild to moderate in severity and were reversible after drug discontinuation.

In addition, oprelvekin is undergoing a pharmacokinetic study among children with chemotherapy-induced platelet depletion.

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