FDA Updates Indications for Temozolomide

M. Alexander Otto, PA, MMS

September 14, 2023

The US Food and Drug Administration (FDA) has updated the indications for temozolomide (Temodar) to include adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and treatment of adults with refractory anaplastic astrocytoma.

One approved indication for temozolomide remains the same: treatment of adults with newly diagnosed glioblastoma, alongside radiotherapy, and then as maintenance treatment.

The changes were made under the agency's Project Renewal program, an "initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date," the agency said today in a press release announcing the update. 

The FDA also updated temozolomide's dosage regimen for newly diagnosed glioblastoma and refractory anaplastic astrocytoma, added information on risks from exposure to opened capsules, and updated patient counseling information and the Patient Information document.

Temozolomide is the second drug to receive a labeling update under the pilot program, following capecitabine (Xeloda). The agency updated capecitabine's label in December 2022 to include eight new or revised indications, including adjuvant treatment of patients with stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen, and perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com

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