NDAINTRACRANIALIMPLANTPriority Review
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Clinical Trials (5)
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Started Aug 2022
50 enrolled
Glioblastoma Multiforme
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
Started Jan 2014
507 enrolled
Malignant Glioma
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Started Jan 2013
561 enrolled
Malignant Glioma
Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)
Started Apr 2011
41 enrolled
Glioblastoma MultiformeGliosarcoma
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
Started Jun 2009
0Glioblastoma Multiforme