March 9, 2009 — Schering-Plough Corporation (Kenilworth, NJ) announced March 5 that the company received approval from the US Food and Drug Administration (FDA) and the European Commission for an intravenous (IV) formulation of temozolomide (Temodar/ Temodal) as an alternative to the currently approved oral form of the drug.
In addition, the European Commission approved sachet packaging for oral temozolomide that will provide "greater patient convenience and flexibility," the company said in a statement.
Temozolomide is a chemotherapy agent approved in the United States for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM) concomitant with radiotherapy and then as maintenance treatment, as well as for refractory anaplastic astrocytoma (AA).
In Europe, it is approved for treatment of patients with newly diagnosed GBM concomitant with radiotherapy and subsequently as monotherapy and for patients with malignant gliomas such as GBM or AA showing recurrence or progression after standard therapy.
Adverse reactions reported from studies of the IV formulation that were not reported in trials of oral temozolomide include pain, irritation, pruritus, warmth, swelling, and erythema at the infusion site, as well as petechiae and hematoma, the release notes.
As bioequivalence for the oral and IV formulations has been established only if the infusion is given over 90 minutes, infusion over a shorter or longer period may result in suboptimal dosing, the statement adds, and the possibility of an increase in infusion-related reactions "cannot be ruled out."
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