Thank you, Nancy. Very interesting. As I understand it, both Empliciti and and Darzalex are monoclonal antibodies, with the former targeting the SLAMF7 antigen and the latter targeting CD38. So the fact that Darzalex is used in Canada in conjunction with Velcade (bortezomib) suggests that combining Empliciti with a proteasome inhibitor (like Ninlaro) may not be far-fetched as a treatment after all.
Curious that my bone marrow report showed no frequency of SLAMF7 versus a “moderate” number of myeloma cells with the CD38 marker.
I also wonder what the synergy could be between a monoclonal antibody treatment versus a proteasome inhibitor such that Empliciti would show no single agent efficacy against myeloma, but would with the addition of a proteasome inhibitor, such that the combination is more effective than either alone.
Forums
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MrPotatohead - Name: MrPotatohead
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: March, 2015
- Age at diagnosis: 65
Re: Empliciti & Ninlaro for multiple myeloma
I hope that helps you. Empliciti (elotuzumab) was approved in Canada as of 2016. So far, Health Canada approved it to be used with Revlimid and dexamethasone.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Empliciti & Ninlaro for multiple myeloma
For the FDA or similar regulatory agencies to approve a drug or drug treatment regimen, a company has to request approval of the drug/regimen, and the request has to include data from one or more clinical trials testing the drug/regimen. Regulatory agencies do not approve the use of a drug or regimen by extrapolating from clinical trial data for other drugs, even if the other drugs are in the same class.
Also, regulatory approval (by the FDA or a similar agency) is not the same as reimbursement approval, at least in countries other than the U.S. Generally, a drug or treatment regimen has to have at least regulatory approval for it even to be considered for reimbursement by central or provincial health authorities.
The FDA-approved use of a drug is always listed in the "indications and usage" section at the beginning of the drug's "prescribing information", or label, which you can find at the FDA website or at the drug's website. For Darzalex, for example, here is a link to the current U.S. prescribing information:
The approved uses ("indications") for Darzalex are as follows:
Also, regulatory approval (by the FDA or a similar agency) is not the same as reimbursement approval, at least in countries other than the U.S. Generally, a drug or treatment regimen has to have at least regulatory approval for it even to be considered for reimbursement by central or provincial health authorities.
The FDA-approved use of a drug is always listed in the "indications and usage" section at the beginning of the drug's "prescribing information", or label, which you can find at the FDA website or at the drug's website. For Darzalex, for example, here is a link to the current U.S. prescribing information:
The approved uses ("indications") for Darzalex are as follows:
- In combination with bortezomib (Velcade), melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- In combination with lenalidomide (Revlimid) and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
- In combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
- As monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
- In combination with lenalidomide (Revlimid) and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.
- In combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Re: Empliciti & Ninlaro for multiple myeloma
Thanks Terry, of course what you report is true. The regulatory agencies give the parameters of how a drug may be used. i know that sometimes a drug company will also later apply for an expanded role of a drug. An example of that here was when Revlimid got approved as a maintenance therapy, years after being approved as a treatment therapy, and also is now allowed for a first line treatment in some patients. So perhaps Bristol Myers Squibb and Abbvie are working on some studies and will try to expand coverage of Empliciiti with proteasome inhibitors, as well as with immunodmodulatory agents, or as a stand alone treatment (with dexamethasone). The company would need clinical data, from studies, to back up a new application.
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Empliciti & Ninlaro for multiple myeloma
Thank you, Nancy. Your post turned out to be very helpful in discussing this issue with my oncologist.
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MrPotatohead - Name: MrPotatohead
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: March, 2015
- Age at diagnosis: 65
Re: Empliciti & Ninlaro for multiple myeloma
You are welcome! To be honest, I got Darzalex confused with Empliciti when I was thinking about it being used with the proteasome inhibitor bortezomib. But I thought that the principle was the same, since they are both in the category of monoclonal antibodies, so maybe your oncologist knew more about that and could advise you. Let us know how everything is working out! Good luck!
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
Re: Empliciti & Ninlaro for multiple myeloma
Here’s an update on my experience after completing two months of treatment with my rather unorthodox combination of Empliciti and Ninlaro.
This regimen, consisting of weekly Empliciti infusions and weekly Ninlaro capsules taken orally (three weeks a month, skipping the last week of the month), has not stopped the slow but steady climb in my kappa free light chains.
So my next treatment plan will probably be Empliciti and Pomalyst. Before my autologous transplant, I tried Pomalyst and could not tolerate the side effects. But I have read that one’s reaction to a drug post-transplant may differ from one’s initial reaction to it.
This regimen, consisting of weekly Empliciti infusions and weekly Ninlaro capsules taken orally (three weeks a month, skipping the last week of the month), has not stopped the slow but steady climb in my kappa free light chains.
So my next treatment plan will probably be Empliciti and Pomalyst. Before my autologous transplant, I tried Pomalyst and could not tolerate the side effects. But I have read that one’s reaction to a drug post-transplant may differ from one’s initial reaction to it.
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MrPotatohead - Name: MrPotatohead
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: March, 2015
- Age at diagnosis: 65
Re: Empliciti & Ninlaro for multiple myeloma
Mr. PH,
I hope that Pomalyst works better for you without nasty side effects. Are you also getting dex in the new protocol? I personally hate dex due to its physical side effects that I suffer under it. However, it does tend to enhance the efficacy of the novel agents it is combined with.
Good Luck!
I hope that Pomalyst works better for you without nasty side effects. Are you also getting dex in the new protocol? I personally hate dex due to its physical side effects that I suffer under it. However, it does tend to enhance the efficacy of the novel agents it is combined with.
Good Luck!
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Ron Harvot - Name: Ron Harvot
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: Feb 2009
- Age at diagnosis: 56
Re: Empliciti & Ninlaro for multiple myeloma
Thanks very much, Ron.
Yes, I believe I will be getting dexamethasone also. The most bothersome side effect I have experienced on it is insomnia; I have been spared some of the worst ill effects others have reported. Still, my doctor has adjusted my dex dosage downward as necessary.
Yes, I believe I will be getting dexamethasone also. The most bothersome side effect I have experienced on it is insomnia; I have been spared some of the worst ill effects others have reported. Still, my doctor has adjusted my dex dosage downward as necessary.
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MrPotatohead - Name: MrPotatohead
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: March, 2015
- Age at diagnosis: 65
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