FDA approves new and updated indications for temozolomide

Written By : Isra Zaman

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2023-09-18 04:30 GMT | Update On 2024-01-29 12:07 GMT

The Food and Drug Administration (FDA) recently approved updated labeling for temozolomide under an 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.

♦ 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 labeling 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 Counseling Information section and the Patient Information document are updated and revised.

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Isra Zaman

Isra Zaman is a Life Science graduate from Daulat Ram College, Delhi University, and a postgraduate in Biotechnology from Amity University. She has a flair for writing, and her roles at Medicaldialogues include that of a Sr. content writer and a medical correspondent. Her news pieces cover recent discoveries and updates from the health and medicine sector. She can be reached at editorial@medicaldialogues.in.

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FDA approves new and updated indications for temozolomide

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