An application to have elotuzumab approved as a new treatment for multiple myeloma has been filed in Europe. The proposed brand name for the drug – at least for Europe – is "Empliciti". The filing of the "Marketing Authorization Application" was announced this morning in a press release issued by Bristol-Myers Squibb (BMS), which, together with AbbVie, will be marketing the drug if it is approved.
As of now, there is no word as to when a U.S. new drug application will be filed. Most likely, it will be sometime in the near future.
The application, which has been approved by European authorities for accelerated review, requests that elotuzumab be approved "for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies."
The application, the press release explains, is based primarily on "data from two randomized clinical trials, each combining Empliciti with a different standard of care regimen for multiple myeloma. ELOQUENT-2, a Phase 3, randomized, open-label study, evaluated Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial were published in The New England Journal of Medicine on June 2. Additionally, a Phase 2, randomized, open-label study (Study CA004-009) evaluated Empliciti with bortezomib and dexamethasone versus bortezomib and dexamethasone alone. These Phase 2 results were presented in an oral session (Abstract #S103) at the 20th Congress of the European Hematology Association (EHA).
Here is a link to the full press release (at The Beacon):
"European Medicines Agency Validates And Grants Accelerated Assessment Of Marketing Authorization Application For Empliciti (Elotuzumab) For The Treatment Of Multiple Myeloma in Patients Who Have Received One Or More Prior Therapies," Bristol-Myers Squibb press release issued July 27, 2015.
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Re: Elotuzumab (Empliciti) European marketing application
Interesting that the first submission for approval was in Europe, rather than the U.S. I don't think that has happened often, or at all, with other new myeloma treatments, such as Pomalyst, Kyprolis, and Farydak.
In any case, thanks for the update. It's great to see things moving along with elotuzumab.
In any case, thanks for the update. It's great to see things moving along with elotuzumab.
Re: Elotuzumab (Empliciti) European marketing application
A key European advisory committee known as CHMP has given a positive opinion on the application to have Empliciti (elotuzumab) approved in Europe as a new treatment for multiple myeloma.
Positive opinions from CHMP almost always lead the European Commission to decide in favor of approving marketing applications such as Empliciti's, so there is a very high chance that Emplicit will be available for use in Europe outside of clinical trials within a couple months.
Here is the press release from Bristol-Myers Squibb with information about the CHMP opinion:
"Bristol-Myers Squibb And AbbVie Receive Positive CHMP Opinion For Investigational Antibody, Empliciti (elotuzumab), For The Treatment Of Multiple Myeloma In Patients Who Have Received At Least One Prior Therapy", Bristol-Myers Squibb press release issued January 29, 2016.
Positive opinions from CHMP almost always lead the European Commission to decide in favor of approving marketing applications such as Empliciti's, so there is a very high chance that Emplicit will be available for use in Europe outside of clinical trials within a couple months.
Here is the press release from Bristol-Myers Squibb with information about the CHMP opinion:
"Bristol-Myers Squibb And AbbVie Receive Positive CHMP Opinion For Investigational Antibody, Empliciti (elotuzumab), For The Treatment Of Multiple Myeloma In Patients Who Have Received At Least One Prior Therapy", Bristol-Myers Squibb press release issued January 29, 2016.
Re: Elotuzumab (Empliciti) European marketing application
Anyone on this forum currently receiving elotuzumab on trial basis?
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Little Monkey - Name: Little Monkey
- Who do you know with myeloma?: Father-stage 1 multiple myeloma
- When were you/they diagnosed?: March/April of 2015
Re: Elotuzumab (Empliciti) European marketing application
Little Monkey,
You can find a list of elotuzumab-related threads at this link:
https://myelomabeacon.org/forum/search.php?keywords=elotuzumab+empliciti&terms=any&author=&sc=1&sf=titleonly&sr=topics&sk=t&sd=d&st=0&ch=300&t=0&submit=Search
In that list, you'll find a couple of threads started by people describing their experience taking elotuzumab. There also are one or two recent threads that ask basically the same question you've asked. (The search box and advanced search functions here in the forum can be very helpful once you get used to using them.)
You can find a list of elotuzumab-related threads at this link:
https://myelomabeacon.org/forum/search.php?keywords=elotuzumab+empliciti&terms=any&author=&sc=1&sf=titleonly&sr=topics&sk=t&sd=d&st=0&ch=300&t=0&submit=Search
In that list, you'll find a couple of threads started by people describing their experience taking elotuzumab. There also are one or two recent threads that ask basically the same question you've asked. (The search box and advanced search functions here in the forum can be very helpful once you get used to using them.)
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JimNY
Re: Elotuzumab (Empliciti) European marketing application
Hi JimNY;
I've found the search function doesn't work as well as it used to. I've tried looking up "Australia" a few times to find a post I wanted to re-read. It came back with no results (I've seen "Australia" a few times on forum post, if not at least ten times).
I've found the search function doesn't work as well as it used to. I've tried looking up "Australia" a few times to find a post I wanted to re-read. It came back with no results (I've seen "Australia" a few times on forum post, if not at least ten times).
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Little Monkey - Name: Little Monkey
- Who do you know with myeloma?: Father-stage 1 multiple myeloma
- When were you/they diagnosed?: March/April of 2015
Re: Elotuzumab (Empliciti) European marketing application
Little Monkey,
Works fine for me. If I just type "Australia" into the forum search box, I get back 9 different forum threads with Australia in the title.
If I do an advanced search on "Australia" or "Australian", I get one additional result. Here's the list.
Sharing search results is a bit tricky, though. If I recall right, the URL from the regular search (not the advanced search) doesn't work when it's shared. Only the URLs from the advanced search work when you share them.
(Sorry, everyone, that this discussion has gone off topic. Didn't mean for that to happen.)
Works fine for me. If I just type "Australia" into the forum search box, I get back 9 different forum threads with Australia in the title.
If I do an advanced search on "Australia" or "Australian", I get one additional result. Here's the list.
Sharing search results is a bit tricky, though. If I recall right, the URL from the regular search (not the advanced search) doesn't work when it's shared. Only the URLs from the advanced search work when you share them.
(Sorry, everyone, that this discussion has gone off topic. Didn't mean for that to happen.)
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JimNY
Re: Elotuzumab (Empliciti) European marketing application
Empliciti (elotuzumab) is now approved in Europe for the treatment of multiple myeloma. The company that markets the drug, Bristol-Myers Squibb, announced the European approval in a press release issued this afternoon.
Here are some excerpts from the press release (edited a bit for readability):
The approval is based on data from the randomized, open-label, Phase 3 ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.
The co-primary endpoints of this study, progression-free survival (PFS) as assessed by hazard ratio (HR) and overall response rate (ORR), were achieved, with extended follow-up data showing a 53% relative improvement in PFS rate at three years (23% versus 15%). Additionally, a pre-specified interim analysis for overall survival (OS) found a positive trend favoring the Empliciti combination versus Rd alone (HR=0.77 [95% CI: 0.61, 0.97, p=0.0257]), though at the time of the interim analysis, the OS endpoint had not reached the pre-determined threshold for statistical significance. Patients will continue to be followed for survival, and the final analysis is pending.
Empliciti with lenalidomide and dexamethasone is associated with the following Warnings and Precautions: infusion reactions, infections, second primary malignancies, hepatotoxicity, interference with determination of complete response ...
The most common adverse reactions (all grades) in ERd and Rd (>10%), respectively, were diarrhea (59.2%, 49.3%), pyrexia (43.0%, 27.7%), fatigue (40.0%, 34.7%), cough (33.2%, 20.3%), nasopharyngitis (29.5%, 27.7%), upper respiratory tract infection (25.2%, 22.7%), lymphopenia (17.6%, 13.6%), headache (17.2%, 9.6%), pneumonia (15.6%, 12.9%) and herpes zoster (10.0%, 5.7%).
Here are some excerpts from the press release (edited a bit for readability):
The approval is based on data from the randomized, open-label, Phase 3 ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.
The co-primary endpoints of this study, progression-free survival (PFS) as assessed by hazard ratio (HR) and overall response rate (ORR), were achieved, with extended follow-up data showing a 53% relative improvement in PFS rate at three years (23% versus 15%). Additionally, a pre-specified interim analysis for overall survival (OS) found a positive trend favoring the Empliciti combination versus Rd alone (HR=0.77 [95% CI: 0.61, 0.97, p=0.0257]), though at the time of the interim analysis, the OS endpoint had not reached the pre-determined threshold for statistical significance. Patients will continue to be followed for survival, and the final analysis is pending.
Empliciti with lenalidomide and dexamethasone is associated with the following Warnings and Precautions: infusion reactions, infections, second primary malignancies, hepatotoxicity, interference with determination of complete response ...
The most common adverse reactions (all grades) in ERd and Rd (>10%), respectively, were diarrhea (59.2%, 49.3%), pyrexia (43.0%, 27.7%), fatigue (40.0%, 34.7%), cough (33.2%, 20.3%), nasopharyngitis (29.5%, 27.7%), upper respiratory tract infection (25.2%, 22.7%), lymphopenia (17.6%, 13.6%), headache (17.2%, 9.6%), pneumonia (15.6%, 12.9%) and herpes zoster (10.0%, 5.7%).
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