NDAINJECTIONINJECTABLE
Approved
Mar 1977
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
BICNU (carmustine) by Accord Biopharma is understood. First approved in 1977.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BICNU (carmustine) is a nitrosourea alkylating agent approved in 1977 for treating malignancies, particularly brain tumors and lymphomas. It works by alkylating DNA and RNA while also inhibiting key enzymatic processes through carbamoylation, with metabolites contributing to both antitumor activity and toxicity. The drug is administered via injection and has a long clinical history across multiple cancer indications.
LOE Approaching
As LOE approaches, commercial teams will shift focus toward lifecycle defense and optimization rather than growth expansion.
Mechanism of Action
understood. While carmustine alkylates DNA and RNA, it is not cross-resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins. The metabolites may contribute to antitumor activity and toxicities of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Started Mar 2025
49 enrolled
LymphomaNon-Hodgkin LymphomaHodgkin Lymphoma
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Started Aug 2022
50 enrolled
Glioblastoma Multiforme
Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme
Started Jun 2009
0Glioblastoma Multiforme
Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma
Started Jun 2008
7 enrolled
Glioma
Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
Started Aug 2003
118 enrolled
Glioblastoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.