FDA Approves New and Updated Indications for Temozolomide Under Project Renewal


On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda).

View full prescribing information for Temodar.

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 is intended to keep older, commonly prescribed oncology drugs’ labeling up-to-date, while providing transparency on FDA’s evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource.

Temozolomide is now approved for the following new and revised indications:

  • adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.
  • treatment of adults with refractory anaplastic astrocytoma.

One approved indication for Temozolomide remains the same:

  • treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.

Additional labeling revisions include:

  • 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.

Project Renewal is limited to updating labeling of older oncology drugs with decades of use, multiple supportive clinical studies, and substantial post-marketing experience. For information on the key studies supporting a new or revised indication, see Temodar’s prescribing information.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology

Source: FDA

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Temodar (temozolomide) FDA Approval History

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