For those who may have missed it, a new antibody-drug conjugate has been approved for multiple myeloma patients who have received at least four prior therapies. The drug is belantamab mafodotin, which will be marketed under the trade name "Blenrep." It's been approved both in the U.S. and in Europe.
There's more information about both approvals in the Beacon's archive of multiple myeloma press releases, specifically:
"FDA Approves GSK’s Blenrep (Belantamab Mafodotin-blmf) For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma," GlaxoSmithKline press release, Aug. 5, 2020.
"European Commission Approves Blenrep (Belantamab Mafodotin) For The Treatment Of Patients With Relapsed And Refractory Multiple Myeloma," GlaxoSmithKline press release, Aug. 26, 2020.
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Mike F - Name: Mike F
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: May 18, 2012
- Age at diagnosis: 53
Re: Blenrep (belantamab mafodotin) approved for myeloma
Thanks, Mike, for making sure everyone here knows about the Blenrep approval.
For those who want more extensive information about Blenrep, the current FDA-approved prescribing information for the drug can be found here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf
The European Medicines Agency (EMA)-approved prescribing information ("Summary of Product Characteristics") can be here:
https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-information_en.pdf
The Blenrep approval is noteworthy for at least two reasons.
First, Blenrep is the first therapy approved anywhere in the world that works by targeting the protein known as "BCMA" (B-cell maturation antigen). BCMA often is found on the surface of myeloma cells, and the protein is a very popular target for potential new myeloma therapies, including what could be the first CAR T-cell therapy approved for multiple myeloma, idecabtagene vicleucel (ide-cel; bb2121).
Second, as you hinted at in your post, Blenrep is the first antibody-drug conjugate approved for the treatment of multiple myeloma.
There were concerns about eye-related side effects associated with Blenrep that led the FDA to convene an advisory committee meeting to review the drug's application for approval. The advisory committee, however, unanimously voted in support of the drug's potential approval (related press release from GSK), and the FDA did eventually approve the drug, although it also included a so-called "black box warning" about the eye-related side effects that can occur during treatment with Blenrep.
For those who want more extensive information about Blenrep, the current FDA-approved prescribing information for the drug can be found here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf
The European Medicines Agency (EMA)-approved prescribing information ("Summary of Product Characteristics") can be here:
https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-information_en.pdf
The Blenrep approval is noteworthy for at least two reasons.
First, Blenrep is the first therapy approved anywhere in the world that works by targeting the protein known as "BCMA" (B-cell maturation antigen). BCMA often is found on the surface of myeloma cells, and the protein is a very popular target for potential new myeloma therapies, including what could be the first CAR T-cell therapy approved for multiple myeloma, idecabtagene vicleucel (ide-cel; bb2121).
Second, as you hinted at in your post, Blenrep is the first antibody-drug conjugate approved for the treatment of multiple myeloma.
There were concerns about eye-related side effects associated with Blenrep that led the FDA to convene an advisory committee meeting to review the drug's application for approval. The advisory committee, however, unanimously voted in support of the drug's potential approval (related press release from GSK), and the FDA did eventually approve the drug, although it also included a so-called "black box warning" about the eye-related side effects that can occur during treatment with Blenrep.
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