Nadofaragene firadenovec and oportuzumab monatox for BCG-unresponsive, non-muscle invasive bladder cancer: effectiveness and value : final report
- Collection:
- Health Policy and Services Research
- Author(s):
- Atlas, Steven J., author Touchette, Daniel R., author Beinfeld, Molly, author McKenna, Avery, author Joshi, Mrinmayee, author Chapman, Rick M., author Pearson, Steven D., author Rind, David M., author
- Contributor(s):
- Institute for Clinical and Economic Review, issuing body.
- Publication:
- [Boston, Massachusetts] : Institute for Clinical and Economic Review, January 15, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Antibodies, Monoclonal -- therapeutic use Urinary Bladder Neoplasms -- drug therapy Genetic Vectors -- therapeutic use United States
- Genre(s):
- Technical Report
- Abstract:
- Current therapies for BCG-unresponsive NMIBC are not successful in many patients, supporting the need for new bladder-preserving treatments. Two such new intravesical therapies are reviewed in this report: (1) Nadofaragene firadenovec (Adstiladrin®) uses a nonreplicating recombinant adenovirus vector that encodes the human interferon alfa-2b gene with Syn3, a polyamide surfactant, to enhance transfer into cancer cells. It is instilled every three months. In May 2020, the US Food and Drug Administration (FDA) issued a Complete Response Letter requesting additional information regarding manufacturing. (2) Oportuzumab monatox (Vicineium®) is a recombinant fusion protein with a humanized anti-epithelial cell adhesion molecule (EpCAM) single-chain antibody linked to Pseudomonas exotoxin A that binds to the cancer cell and then releases the toxin into the cell, inducing cell death.15 It is instilled twice a week for six weeks, then weekly for six weeks and then every two weeks for up to two years. A rolling Biologics License Application (BLA) was submitted in December 2019.
- Copyright:
- Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
- Extent:
- 1 online resource (1 PDF file (various pagings))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918231204106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918231204106676