FDA Approves New, Updated Indications for Temozolomide

Labeling Update Comes Under Project Renewal

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On September 14, the U.S. Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar) for the treatment of CNS cancers under Project Renewal, an Oncology Center of Excellence 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).

Temozolomide Labeling Updates

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 temozolomide capsules, information on risks from exposure to opened capsules has been added under warnings and precautions.
  • The patient counseling information section and the patient information document are updated and revised.

More on Project Renewal

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 the FDA’s evaluation process and evidentiary standards, as well as improving awareness of drug labeling as an information resource.

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