FDA Approves New Label for Temozolomide in Multiple Cancers


There are 2 new FDA indications for temozolomide.

  • Under the FDA’s Project Renewal, the label for temozolomide has been changed.1

  • Project Renewal aims to update labeling information for older oncolytic agents.

  • The first drug approved as part of the Project Renewal program was the chemotherapy product, capecitabine.

The FDA has granted approval for an updated labeling of temozolomide (Temodar). Under the updated label, temozolomide has 2 new indications and 3 revisions.1

Temozolomide is newly approved for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma as well as for adult patients with refractory anaplastic astrocytoma. Temozolomide also continues to be an FDA-approved therapy with radiotherapy and maintenance therapy to treat adult patients with newly diagnosed glioblastoma.

Revisions to the label for temozolomide include a revised dosing to the drug’s newly diagnosed glioblastoma and refractory anaplastic astrocytoma indications, new warnings and precaution about the capsule formulation of the drug, and an update to the Patient Counseling Information section of the label.

The first new drug application for temozolomide was reviewed 1999, which lead to the FDA approval of the drug in capsule formation in adult patients with anaplastic astrocytoma whose disease progressed on a drug regimen containing nitrosourea and procarbazine.2 The newly diagnosed glioblastoma indication was granted in 2005.3


1. FDA approves new and updated indications for temozolomide under Project Renewal. News release. FDA.gov. September 14, 2023. Accessed September 14, 2023. https://tinyurl.com/yzy3dynz

2. Temodar (Temozolomide) capsules. FDA.gov. Accessed September 14, 2023. https://tinyurl.com/yu6f2n59

3. Cohen MH. Food and Drug Administration drug approval summary: Temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme. Clin Can Res. 2005;11(19): 6767–6771. doi:10.1158/1078-0432.CCR-05-0722

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