FDA Approves New and Updated Indications for Temozolomide Under Project Renewal
On September 14, 2023, the U.S. Food and Drug Administration (FDA) approved new labeling for temozolomide (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal) (Temodar®) under Project Renewal (https://www.fda.gov/about-fda/oncology-center-excellence/project-renewal), an Oncology Center of Excellence (OCE) initiative that updates labeling information for older oncology drugs to ensure it is clinically meaningful and scientifically current. This is the second drug—both anticancer agents—to receive a labeling update under the pilot program. The first was capecitabine (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approves-updated-drug-labeling-including-new-indications-and-dosing) (Xeloda®).
Temozolomide is now approved (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal) for the following new and revised indications:
- Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma
- Treatment of adults with refractory anaplastic astrocytoma
Its previous indication for the treatment of adults with newly diagnosed glioblastoma, administered concomitantly with radiotherapy and then as maintenance treatment, remains the same (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal).
Additionally,
- The dosage regimen was revised and updated for newly diagnosed glioblastoma and refractory anaplastic astrocytoma.
- Information on risks from exposure to opened capsules was added under the Warnings and Precautions section.
- The Patient Counseling Information section and Patient Information document were updated and revised.
For information on the key studies supporting the updated indication, see temozolomide’s full prescribing information (http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s036_037_038lbl.pdf).
Project Renewal (https://www.fda.gov/about-fda/oncology-center-excellence/project-renewal) is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal keeps older, commonly prescribed oncology drugs’ labeling up to date; provides transparency on FDA’s evaluation process and evidentiary standards; and improves awareness of drug labeling as an information resource.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine or device to FDA’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.
For assistance with single-patient investigational new drug applications, contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).