temozolomide capsules — Medica

Initial criteria

• Anaplastic astrocytoma – Approve for 1 year.
• Glioblastoma multiforme – Approve for 1 year.
• Bone cancer – Approve for 1 year IF patient has tried one chemotherapy regimen AND diagnosis of Ewing sarcoma OR mesenchymal chondrosarcoma.
• Brain metastases from solid tumors – Approve for 1 year.
• Ependymoma (intracranial or spinal) – Approve for 1 year.
• Glioma (other types) – Approve for 1 year.
• Gliosarcoma – Approve for 1 year.
• Medulloblastoma – Approve for 1 year IF recurrent or progressive disease.
• Melanoma – Approve for 1 year IF unresectable or metastatic AND has tried one systemic regimen OR is not a candidate for a systemic regimen.
• Mycosis Fungoides/Sézary Syndrome – Approve for 1 year IF has tried at least one prior therapy AND has CNS involvement.
• Neuroblastoma – Approve for 1 year IF high risk disease AND used in combination with chemoimmunotherapy.
• Neuroendocrine tumors – Approve for 1 year IF any of: carcinoid or GI/lung/thymus NET; islet cell or pancreatic NET; extrapulmonary poorly differentiated neuroendocrine carcinoma; large/small cell carcinoma; mixed neuroendocrine-non-neuroendocrine neoplasm; well differentiated grade 3 NET.
• Pheochromocytoma or paraganglioma – Approve for 1 year IF unresectable or metastatic disease.
• Primary central nervous system lymphoma – Approve for 1 year.
• Small cell lung cancer – Approve for 1 year IF has tried one systemic regimen.
• Soft tissue sarcoma – Approve for 1 year IF advanced or metastatic disease.
• Uterine sarcoma – Approve for 1 year IF has tried a chemotherapy regimen.
• Uveal melanoma – Approve for 1 year IF unresectable or metastatic disease.

Approval duration

1 year