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temozolomide capsules — Medica

gliosarcoma

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