FDA approves new and updated indications for temozolomide

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.