Updated Indications for Brain Cancer Chemotherapy
The FDA Project Renewal initiative has updated the approved indications for temozolomide chemotherapy in anaplastic astrocytoma.
The U.S. Food and Drug Administration (FDA) has approved updated labeling of temozolomide (Temodar), including new and revised indications for the treatment of anaplastic astrocytoma, a type of brain cancer.
The approvals occurred under Project Renewal, an initiative of the Oncology Center of Excellence aimed at reviewing real-world data to update the approved indications for older drugs. While most FDA approvals happen while a drug retains patent protections, off-patent drugs that have existed for decades are no longer evaluated in the types of large clinical trials that garner new approvals. Project Renewal analyzes data from smaller studies investigating off-label uses for these drugs to update the approval indications. AACR is a strategic partner of Project Renewal, providing scientific advice and perspective.
Temozolomide is a chemotherapy drug that makes chemical modifications to the DNA of rapidly dividing cells, such as tumor cells. These modifications damage the DNA, leading to tumor cell death.
The updated labeling included a new indication for temozolomide to treat adults with newly diagnosed anaplastic astrocytoma. It also revised the indications for the treatment of adults with anaplastic astrocytoma that did not respond to or recurred following other therapies.
Temozolomide is also approved to treat newly diagnosed glioblastoma, another type of brain cancer. It can be used in combination with radiotherapy for initial treatment; then, it can be given individually as a maintenance therapy to prevent glioblastoma recurrence.
Anaplastic astrocytoma is a type of glioma, a type of tumor that forms from glial cells in the brain and spinal cord. Anaplastic astrocytoma is the most common glioma diagnosed in children and teenagers.
The FDA rendered its decision on September 14, 2023.
