Elotuzumab (trade name: Empliciti) has been approved in Germany since May 2016 for the treatment of multiple myeloma. The drug is an option for adults who have already had treatment at least once. It is combined with the medications lenalidomide and dexamethasone. Its approval was expanded in August 2019: It is now also an option in combination with pomalidomide and dexamethasone for people who have had at least 2 unsuccessful treatments.
Multiple myeloma is a rare type of cancer in which mutated plasma cells multiply uncontrollably in the bone marrow. If the disease progresses, it destroys bone tissue and prevents normal blood formation. This can cause bone pain and bone fractures, as well as anemia. In addition, multiple myeloma weakens the immune system and is a life-threatening disease.
The new drug aims to stimulate the immune system to attack the tumor cells.
Elotuzumab is given as an infusion (a drip) in combination with dexamethasone and lenalidomide in 28-day cycles. During the first two cycles, patients receive one infusion per week. After that, the drug is given every two weeks.
Elotuzumab is also given in 28-day cycles when used in combination with dexamethasone and pomalidomide. During the first two cycles, patients receive one infusion per week. After that, this combination of medications is only given every four weeks.
Depending on what previous treatments someone has had, the standard treatments for multiple myeloma include lenalidomide, proteasome inhibitors such as bortezomib or carfilzomib, and pomalidomide alone or in various combinations.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether elotuzumab has any advantages or disadvantages compared to the standard treatments for multiple myeloma in people who have already had at least one treatment.
But the manufacturer didn’t provide any suitable data with which to do the assessment.
In 2019, IQWiG looked into whether elotuzumab has any advantages or disadvantages compared to the standard treatments for multiple myeloma that has become worse despite previous treatments.
For the purpose of this assessment, the manufacturer provided one study involving 117 patients. One half of these patients had treatment with elotuzumab in combination with the standard treatment of pomalidomide and dexamethasone, while the other half had only the standard treatment. All of the participants in the study had multiple myeloma that had got worse despite having had at least 2 previous treatments (including lenalidomide and/or proteasome inhibitors). The following results were found for this group of people:
What are the advantages of elotuzumab?
Life expectancy: The study suggests that elotuzumab has an advantage here. While the people who were given the standard treatment passed away after about 17 months on average (median value), the people who also received elotuzumab passed away only after 30 months at the earliest.
Severe side effects: The study suggests that elotuzumab has an advantage here, but only in people who haven't had more than 3 previous treatments: Severe side effects occurred in about 57 out of 100 people who took elotuzumab, compared to nearly 89 out of 100 people who had the standard treatment.
There was no difference in people who had 4 or more previous treatments.
What are the disadvantages of elotuzumab?
The available data shows no disadvantages for elotuzumab when compared with the standard treatment.
There was no difference in terms of:
- General health
- Severity of symptoms
- Limitations in everyday life due to symptoms
- Treatment stopped due to side effects
What remains unanswered?
The manufacturer didn't provide any data about quality of life.
This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of elotuzumab (Empliciti) in 2016 and in 2019.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Elotuzumab – Benefit assessment according to §35a Social Code Book V; Dossier assessment; Commission A16-32. August 29, 2016.(IQWiG reports; Volume 426).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Elotuzumab (multiple myeloma) – Addendum to Commission A16-32; Commission A16-66. November 9, 2016. (IQWiG reports; Volume 458).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Elotuzumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V; Dossier assessment; Commission A19-80. December 20, 2019. (IQWiG reports; Volume 857).
IQWiG health information is written with the aim of helping
people understand the advantages and disadvantages of the main treatment options and health
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