Elotuzumab Receives Breakthrough Therapy Designation For Multiple Myeloma
Published: May 19, 2014 11:11 am; Updated: May 21, 2014 1:25 pm
The pharmaceutical companies Bristol-Myers Squibb and AbbVie announced this morning that the U.S. Food and Drug Administration has granted breakthrough therapy designation to the investigational drug elotuzumab.
Specifically, the Food and Drug Administration (FDA) granted breakthrough therapy designation to elotuzumab in combination with Revlimid (lenalidomide) and dexamethasone (Decadron) for multiple myeloma patients who have received one or more prior therapies.
The breakthrough therapy designation is a new designation that was signed into law in 2012. It is designed to accelerate the development and review process for drugs intended to treat serious or life-threatening illnesses.
Elotuzumab is now the second potential new myeloma treatment that has received the breakthrough therapy designation. Daratumumab received the designation in May of last year (see related Beacon news).
Currently, The Beacon estimates that elotuzumab could be approved by the FDA and launched in the U.S. as a new treatment for multiple myeloma by late 2015 or early 2016. Approval in Europe is likely to follow shortly thereafter. Launches in specific European countries would then occur throughout the rest of 2016.
These projections are based on data provided to The Beacon by Evaluate Ltd., a market intelligence and analysis firm, and on discussions with financial analysts at International Strategy & Investment (ISI) and Sanford C Bernstein & Co.
Elotuzumab is being developed by Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE:ABBV). It belongs to a class of drugs called monoclonal antibodies, which work by identifying proteins on the surface of cancer cells and signaling for the immune system to destroy the cells.
In the case of elotuzumab, a protein known as CS1 is targeted by the drug. CS1 is commonly found on the surface of myeloma cells. In the case of daratumumab, SAR650984, and MOR202 – which also are monoclonal antibodies being developed as potential myeloma therapies – a protein known as CD38 is targeted by the drugs.
The breakthrough therapy designation for elotuzumab is based on findings from a Phase 2 study that assessed elotuzumab in combination with Revlimid and low-dose dexamethasone for the treatment of multiple myeloma patients who have received one or more prior therapies.
Results of that trial showed that elotuzumab in combination with Revlimid and low-dose dexamethasone demonstrates substantial response rates and favorable progression-free survival in this patient population (see related Beacon news).
One of the doses tested in that trial (10 mg/kg) is currently being investigated in Phase 3 trials.
For more information about elotuzumab's breakthrough therapy designation, please see the related press release issued by BMS and AbbVie.
Note: This article was updated on Wednesday, May 21, to incorporate revised projections of elotuzumab's U.S. and European approval and launch dates.
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- bb2121 Continues To Impress As Potential New Multiple Myeloma Therapy (ASCO 2018)
- Lather, Rinse, Repeat: Will It Work With BCMA-Targeted Therapies For Multiple Myeloma?
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This is great news for anyone in the US wanting to try a monoclonal antibody treatment! It is used in combination with lenalidomide/dex, for a a relapsed patient having tried one or more prior therapies (and what MM patient hasn't been treated for at least that much?).
When I looked up the 'Eloquent 1' clinical trial, I found that it is a two armed trial ( rev/dex in both arms, and elotuzumab in one arm, randomized), of Phase 3 level for NDMM patients (newly diagnosed). Eloquent 1 is being run in over 600 locations, including all over the US, in Canada, Australia, Europe and more!
We are just having a great week for research news about myeloma treatments. Thank you, Beacon Staff, for making sure we are kept informed and 'in the loop'!
Nancy, I have my husband with newly diagnosed hyperdiploid MM with low risk designation. How do I find trials that he could enter to receive this new treatment? We are overwhelmed as to how to proceed in fighting this disease. Thank you, Carol Cann
Hello Carol,
The most comprehensive resource for finding clinical trials is http://www.clinicaltrials.gov . It's not hard to use, and if you use the "Advanced Search" feature, you can restrict the search results to only include, for example, trials with locations in certain states (or countries).
It's worth taking the time to get familiar with it because, once you are, it can prove very valuable.
Good luck!
I agree with Nancy - this is a very good week for new therapies!
Please note that, after additional research, we have updated this article to include revised projections of elotuzumab's launch date in the U.S. We also have added a projection for the drug's potential European approval date.
Thanks Beacon Staff!
Always nice to have a date to shoot for, with theses drugs--far off treatments don't seem quite "forever', ....when we get a date certain.
Thank you.
Beacon Staff--what can you tell us about this 'un ?
Generation of a new therapeutic peptide that depletes myeloid-derived suppressor cells in tumor-bearing mice
Hong Qin, Beatrisa Lerman, Ippei Sakamaki, Guowei Wei, Soungchul C Cha, Sheetal S Rao, Jianfei Qian, Yared Hailemichael, Roza Nurieva, Karen C Dwyer, Johannes Roth, Qing Yi, Willem W Overwijk and Larry W Kwak
Using Peptides to take out Tumor "Sentry cells", which prevent normal Immune system responses, in cancer.
Thanks.
Will this new drug be an option for non-secretory patients?
Thank you
Debbie
R - We'll look into the study you mentioned. Thanks.
Debbie - If elotuzumab is approved as a new myeloma therapy, we expect that it will be approved for use in non-secretory patients as well as secretory patients.
It is true that non-secretory patients often cannot participate in clinical trials. However, this is mainly because it is more difficult to determine a non-secretory patient's response to treatment. It does not mean that the drugs that are eventually approved based on such trials will not be allowed to be used in non-secretory patients.
For example, the clinical trial that led to the approval of Kyprolis did not allow participation by non-secretory patients. But there is nothing in the official, FDA-approved prescribing information for Kyprolis that suggests or recommends that the drug not be used in non-secretory patients.
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