Add Formweb to your mobile device
Search results for:
belantamab mafodotin
belantamab mafodotin
Brand names: Blenrep
| Form | Strength | ANAN | ASMP | LACH | LALK | LOHH | LOLR | LOWC | SDSD | SESE | SFSF | Formulary Status |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| POWDER FOR INJECTION, INTRAVENOUS | 100 mg | Non-formulary |
Last updated: Dec. 12, 2022
- Black Box Warning: Ocular Toxicity
- Hazardous Drugs: View Hazardous Waste List
- REMS: View FDA REMS info
- REMS: FDA Med Guide List
11/22/2022 - GSK announced it has initiated the process for withdrawal of the US marketing authorization for Blenrep following the request of the US Food and Drug Administration (FDA). This request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the US FDA Accelerated Approval regulations. GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorization | GSK US