FDA expands approval of Temodar to treat brain cancer
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The FDA expanded use of Temodar to include new and updated indications for the treatment of adults with anaplastic astrocytoma.
Temozolomide (Temodar, Merck) — an alkylating agent — received previous approval for treatment of adults with newly diagnosed glioblastoma, concomitant with radiotherapy and then as maintenance treatment.
The new and revised indications include as adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and for treatment of adults with refractory anaplastic astrocytoma.
The expansion is part of FDA’s Project Renewal, a pilot program aimed at maintaining up-to-date labeling for older oncology drugs.
“Project Renewal is limited to updating labeling of older oncology drugs with decades of use, multiple supportive clinical studies and substantial post-marketing experience,” the FDA said in a press release.
Frequently reported treatment-related toxicities in 20% or more of patients using temozolomide include alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, and convulsions.
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