[Beacon Staff]

FDA approves Empliciti (elotuzumab)

by Beacon Staff on Mon Nov 30, 2015 1:22 pm

Breaking news - The FDA today approved elotuzumab as a new treatment for multiple myeloma. The drug, which will be sold under the brand name "Empliciti", had been approved for use in combination with Revlimid and dexamethasone in patients who have one to three prior therapies.

Here is a link to the FDA press release with information on the approval:

FDA Approves Empliciti, A New Immune-Stimulating Therapy To Treat Multiple Myeloma, FDA press release, Nov 30, 2015

Here are key excerpts from the press release:

Today the U.S. Food and Drug Administration granted approval for Empliciti (elo­tuzu­mab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medi­ca­tions ...

“We are continuing to learn about the ways the immune system interacts with dif­fer­ent types of cancer, in­clud­ing multiple myeloma," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval is the second mono­clonal antibody approved to treat patients with multiple myeloma and works with another approved therapy to provide additional benefit." Darzalex (daratumumab), approved earlier this month, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma.

Empliciti activates the body’s immune system to attack and kill multiple myeloma cells. It is approved in combination with another FDA-approved treatment for multiple myeloma called Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid).

The safety and efficacy of Empliciti were tested in a randomized, open-label clinical study of 646 participants whose multiple myeloma came back after, or did not re­spond to previous treatment. Those taking Empliciti plus Revlimid and dexa­metha­sone experienced a delay in the amount of time before their disease worsened (19.4 months) compared to participants taking only Revlimid and dexa­metha­sone (14.9 months). Addi­tion­ally, 78.5 percent of those taking Empliciti with Revlimid and dexa­metha­sone saw a complete or partial shrinkage of their tumors compared to 65.5 percent in those only taking Revlimid and dexa­metha­sone.

The most common side effects of Empliciti are fatigue, diarrhea, fever (pyrexia), con­stipation, cough, nerve damage resulting in weakness or numbness in the hands and feet (peripheral neuropathy), infection of the nose and throat (naso­pharyngitis), upper respiratory tract infection, decreased appetite and pneumonia.

[Multibilly]

Re: FDA approves Empliciti (elotuzumab)

by Multibilly on Mon Nov 30, 2015 1:52 pm

It's been a heckuva month for the FDA and multiple myeloma drug approvals. This is great news.

[BeatMyeloma]

Re: FDA approves Empliciti (elotuzumab)

by BeatMyeloma on Mon Nov 30, 2015 2:20 pm

Woohoo! That is great news. Anyone want to bet what drug is next?

[Beacon Staff]

Re: FDA approves Empliciti (elotuzumab)

by Beacon Staff on Mon Nov 30, 2015 3:02 pm

For those who might be interested, here is the Empliciti prescribing information:

EmplicitiPrescribingInformation.pdf

(654.54 KiB) Downloaded 79 times

[Ellen Harris]

Re: FDA approves Empliciti (elotuzumab)

by Ellen Harris on Mon Nov 30, 2015 3:46 pm

This is wonderful news for us!

[Nancy Shamanna]

Re: FDA approves Empliciti (elotuzumab)

by Nancy Shamanna on Mon Nov 30, 2015 4:08 pm

I am so glad and grateful to hear about this latest approval of elotuzumab. When I started to go to patient education talks a few years ago, the advice was 'Hang in there, for in a few years, there will be better treatments available!' I think that in the US, that day may have arrived!

I know that all of the recently approved drugs have been tested by clinical trials in Canada and in other countries too. I can only hope that we will also be having these new drugs here, and that is a day that will be welcomed by many patients and caregivers.

[Beacon Staff]

Re: FDA approves Empliciti (elotuzumab)

by Beacon Staff on Mon Nov 30, 2015 6:49 pm

Hi everyone,

Thanks for all the comments.

We've got a bit more reading for you related to the Empliciti approval ...

First, the FDA issued a slightly more detailed press release about the Empliciti approval.

In addition, the two companies that have been developing Empliciti – Bristol-Myers Squibb and AbbVie – issued a rather long press release with information about the approval:

"Bristol-Myers Squibb And AbbVie Receive FDA Approval of Empliciti™ (Elotuzumab) For The Treatment Of Patients With Multiple Myeloma Who Have Received One To Three Prior Therapies," Bristol-Myers Squibb & AbbVie press release, Nov 30, 2015.

[Multibilly]

Re: FDA approves Empliciti (elotuzumab)

by Multibilly on Mon Nov 30, 2015 8:19 pm

Hi Beacon Staff,

Any guesses as to why elotuzumumab is approved for patients with 1-3 prior therapies while daratumumab is only approved with patients that have gone through 3 prior herapies?

[Boris Simkovich]

Re: FDA approves Empliciti (elotuzumab)

by Boris Simkovich on Mon Nov 30, 2015 8:38 pm

Hi Multibilly,

Generally, the FDA approves a drug for use in patients similar to those that were in the trial(s) that provide the data supporting a new drug application.

The main daratumumab trial was carried out with patients who had to have at least three prior therapies to participate in the study. Hence the approval for that specific patient group.

Likewise, the elotuzumab trial included only patients who had 1 to 3 prior therapies. Once again, the approval for the drug mirrors that requirement.

[MrPotatohead]

Re: FDA approves Empliciti (elotuzumab)

by MrPotatohead on Mon Nov 30, 2015 8:46 pm

This is really wonderful news. My oncologist is very optimistic about the potential for these new antibody-based therapies, and it is great being able to get this kind of detailed information on the Beacon site.