Temozolomide Prescribing Information Updated Under FDA’s Project Renewal Program

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Temozolomide is the second drug to receive a labeling update under Project Renewal.

The Food and Drug Administration (FDA) has approved updated labeling for temozolomide (Temodar) under Project Renewal, a public health initiative established by the FDA’s Oncology Center of Excellence.

Utilizing a network of external oncology experts and early career scientists, the collaborative program is intended to keep the labeling for commonly prescribed older oncology medications updated through a review of existing published literature.

Temozolomide is the second drug to receive label changes under this program, the first drug being capecitabine (Xeloda). The labeling for temozolomide has now been updated to include the following new and revised indications:

  • Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.
  • Treatment of adults with refractory anaplastic astrocytoma.

The indication for treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment, remains unchanged.

Additional revisions to the temozolomide prescribing information include:

  • A revised and updated dosage regimen for newly diagnosed glioblastoma and refractory anaplastic astrocytoma.
  • Information on 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. 
  • 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.


  1. US Food and Drug Administration. FDA approves new and updated indications for temozolomide under Project Renewal. September 14, 2023. Accessed September 15, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal.
  2. Temodar. Package insert. Merck; 2023. Accessed September 15, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf.