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

Full prescribing information for Temodar is available here.

Project Renewal is a collaborative programme 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’ labelling up-to-date, while providing transparency on FDA’s evaluation process and evidentiary standards, and improving awareness of drug labelling 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 labelling 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 Counselling Information section and the Patient Information document are updated and revised.

Project Renewal is limited to updating labelling 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.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate.