The US Food and Drug Administration (FDA) has approved updated labeling for temozolomide (Temodar) under Project Renewal, a public health initiative created to keep the labeling for older oncology medications updated through a review of existing published literature.

The labeling for temozolomide has been updated to include adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and treatment of adults with refractory anaplastic astrocytoma. The indication for adults with newly diagnosed glioblastoma, given concomitantly with radiotherapy and then as maintenance treatment, remains unchanged.

Another new addition to the temozolomide prescribing information is a revised and updated dosage regimen for newly diagnosed glioblastoma and refractory anaplastic astrocytoma.

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The prescribing information also contains details about risks from exposure to opened temozolomide capsules. Patients are advised not to open, chew, or dissolve the contents of the capsules. If capsules must be opened or the contents must be dissolved, this should be done by a professional trained in the safe handling of hazardous drugs. 

Lastly, the Patient Counseling Information section and the Patient Information document have been updated and revised.

Studies supporting the new or revised indications are available in the updated prescribing information.

Project Renewal was established by the FDA’s Oncology Center of Excellence. Temozolomide is the second drug to receive label changes under this program. The first was capecitabine (Xeloda).


US Food and Drug Administration. FDA approves new and updated indications for temozolomide under Project Renewal. September 14, 2023. Accessed September 15, 2023.

Temodar. Package insert. Merck; 2023. Accessed September 15, 2023.

This article originally appeared on MPR