FDA approves IV form of temozolomide

Intravenous temozolomide, an alternative to the already approved oral form of the drug, received approval from the FDA and European Commission for the treatment of adults with glioblastoma multiforme. In the United States, the drug is approved for use with radiotherapy, as maintenance therapy and for patients with refractory anaplastic astrocytoma.

In March 2005 oral temozolomide (Temodar, Schering-Plough) received FDA approval in this patient population. Now, the IV form provides an alternative method of administration.

Bioequivalence between the two forms was established when the IV form was given over 90 minutes. According to a press release, infusions over longer or shorter periods of time may result in suboptimal dosing, and the possibility of an increase in infusion-related adverse events cannot be ruled out.

Data from two trials of temozolomide, in both the concomitant and maintenance phases for patients with newly-diagnosed glioblastoma multiforme, revealed the most common adverse events to be alopecia, fatigue, nausea, vomiting, anorexia, headache, rash and constipation. Convulsions and thrombocytopenia were also reported.

In trials of patients with refractory anaplastic astrocytoma, the most common adverse events were nausea, vomiting, headache, fatigue, constipation and convulsions. Hemiparesis and asthenia were also reported. Additional adverse events reported for the IV formulation that were not reported for the oral formulation include: pain, irritation, pruritus, warmth, swelling and erythema at infusion site. Petechiae and hematoma were also reported.