FDA Approves New and Updated Indications for Temozolomide in Anaplastic Astrocytoma

FDA

The FDA has approved temozolomide (Temodar) for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma. Under Project Renewal, the regulatory agency has also revised indications for the treatment of patients with refractory anaplastic astrocytoma.¹

On the updated label, one indication for temozolomide remained the same. It is still approved for the treatment of adult patients with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.

The updated label also contains the following revisions:

• The dosage regimen is revised and updated for newly diagnosed glioblastoma and refractory anaplastic astrocytoma.
• For Temodar capsules, information on risks from exposure to opened capsules is added under Warnings and Precautions.
• Patient Counseling Information section and the Patient Information document are updated and revised.

The purpose of Project Renewal is updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. Temozolomide second drug to receive an updated label under the pilot program after capecitabine (Xeloda) received an updated label in December 2022.²

References

1. FDA approves new and updated indications for temozolomide under Project Renewal. News release. FDA. September 14, 2023. Accessed September 14, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal
2. FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal. News release. FDA. December 14, 2022. Accessed September 14, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-including-new-indications-and-dosing-regimens-capecitabine