In a significant development, the FDA has granted approval for temozolomide (marketed as Temodar) to be used as adjuvant therapy for newly diagnosed anaplastic astrocytoma in adult patients. This decision comes as part of Project Renewal, an initiative aimed at revising indications for treating refractory anaplastic astrocytoma.
While one indication on the temozolomide label for treating adult patients with newly diagnosed glioblastoma alongside radiotherapy and as maintenance therapy remains unchanged, there are notable revisions on the updated label:
- Dosage Regimen Updates: The dosage regimen for both newly diagnosed glioblastoma and refractory anaplastic astrocytoma has been revised and updated to reflect current clinical guidelines.
- Added Risk Information: Specifically for Temodar capsules, the label now includes information regarding potential risks associated with exposure to opened capsules. This addition falls under the Warnings and Precautions section, enhancing patient safety.
- Patient Counseling and Information: The Patient Counseling Information section and the Patient Information document have undergone thorough updates and revisions, ensuring that patients and healthcare providers have access to the most current and relevant information.
Project Renewal aims to keep labeling information for older oncology drugs clinically meaningful and scientifically up-to-date. Temozolomide is the second drug to receive an updated label through this pilot program, following capecitabine (Xeloda), which received its updated label in December 2022.
These label updates not only reflect the FDA’s commitment to ensuring accurate and pertinent drug information but also hold significant implications for healthcare professionals and patients dealing with anaplastic astrocytoma, furthering the understanding and application of temozolomide in clinical practice.
