New indication for Oncaspar given OK
The PEG-enhanced version of L-asparaginase, pegaspargase (Oncaspar, Enzon Pharmaceuticals), has been approved by the FDA as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). The biologic was approved in 1994 only for patients with ALL who were allergic to L-asparaginase.
New indication for Oncaspar given OK
The PEG-enhanced version of L-asparaginase, pegaspargase (Oncaspar, Enzon Pharmaceuticals), has been approved by the FDA as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). The biologic was approved in 1994 only for patients with ALL who were allergic to L-asparaginase. In clinical trials, pegaspargase demonstrated a three-year event-free survival rate of approximately 80%. Due to its longer half-life, said the manufacturer, one dose of pegaspargase results in antileukemic activity similar to six to nine doses of unmodified L-asparaginase, resulting in a more convenient dosage regimen of every 14 days versus twice weekly.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
