FDA's Project Renewal leads to updated labeling for Temodar

The US Food and Drug Administration has approved updated labeling for Temodar (temozolomide), a legacy oncology drug developed by Merck & Co (NYSE: MRK).

Under the agency’s Project Renewal initiative, which is run by the Oncology Center of Excellence (OCE), the move ensures labeling information remains “clinically meaningful and scientifically up-to-date.”

Temodar is now additionally approved for the adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma, and the treatment of adults with refractory anaplastic astrocytoma.