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:
One approved indication for temozolomide remains the same:
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.