FDA approves new and updated indications for temozolomide under Project Renewal
Regulatory approval: On Sept 14, 2023, the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence initiative to modernize labeling for older oncology drugs. The update includes new/revised indications in adult anaplastic astrocytoma and retains the adult newly diagnosed glioblastoma indication. Labeling changes also revise dosing regimens and add capsule-handling risk information.
FDA labeling update for temozolomide under Project Renewal (Sept 14, 2023)
Type: Regulatory approval (labeling update)
On September 14, 2023, the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence initiative intended to ensure labeling for older oncology drugs remains clinically meaningful and scientifically up to date. Temozolomide is the second drug to receive a labeling update under this pilot program; capecitabine (Xeloda) was the first.
New and revised indications now approved
- Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma
- Treatment of adults with refractory anaplastic astrocytoma
Indication unchanged
- Treatment of adults with newly diagnosed glioblastoma, given concomitantly with radiotherapy and then as maintenance treatment
Additional labeling revisions
- Dosage regimen revised/updated for newly diagnosed glioblastoma and refractory anaplastic astrocytoma
- For Temodar capsules, added Warnings and Precautions information on risks from exposure to opened capsules
- Patient Counseling Information section and Patient Information document updated
Project Renewal relies on review of published literature by external oncology experts and early-career scientists for independent FDA review; key supporting studies are referenced in the prescribing information.