A European Medicines Agency (EMA) panel has recommended that elotuzumab (Empliciti, Bristol-Myers Squibb) be granted marketing authorization for the treatment of multiple myeloma.
The agent is used in combination with lenalidomide (Revlimid, Celgene) and dexamethasone (multiple brands) in patients who have received at least one previous therapy.
Elotuzumab was approved for the same indication by the US Food and Drug Administration in 2015.
Elotuzumab is the first immune-based therapy to show benefit in the treatment of multiple myeloma.
The monoclonal antibody targets the cell-surface protein SLAMF7, which is found on myeloma cells and on natural killer (NK) cells. It offers a two-pronged attack on cancer by targeting myeloma cells directly and by enhancing the ability of NK cells to kill myeloma cells.
"It's a bit of a double whammy," investigator Sagar Lonial, MD, from the Winship Cancer Institute of Emory University in Atlanta, said last year, as reported by Medscape Medical News.
As was the case in the United States, the basis for the pending European approval is a trial known as ELOQUENT-2 (NCT01239797), a randomized open-label clinical study that involved 646 participants with multiple myeloma who had experienced relapse or who had not responded to previous treatment. Results from the trial were published last year (New Engl J Med. 2015;373:621-631).
The addition of elotuzumab to the combination of lenalidomide plus dexamethasone extended progression-free survival by 4.2 months, compared with treatment with lenalidomide and dexamethasone alone (control group).
Additionally, the overall response rate was better in the elotuzumab group than in the control group (78.5% vs 65.5%).
Dr Lonial and his colleagues noted last year that two subgroups of study participants with high-risk features — those with the genetic abnormality del(17p) and those with genetic abnormality t(4;14) — appeared to benefit from elotuzumab as much as average-risk patients. Conventional therapies tend to be less effective in high-risk patients, they explained during a presscast associated with the 2015 annual meeting of the American Society of Clinical Oncology.
The most common adverse events seen with elotuzumab are infusion-related reactions, diarrhea, cough, herpes zoster, nasopharyngitis, pneumonia, upper respiratory tract infection, lymphopenia, and weight loss.
Dr Lonial reported last year that adding elotuzumab to the standard therapy did not significantly increase adverse events. Overall, the drug was well tolerated and did not cause a deterioration of quality of life or exacerbate symptom burden, he added.
In 2012, there were approximately 39,000 people with multiple myeloma in the European Union. With currently available treatment, 5-year survival is less than 50% in these patients, according to the EMA. New therapies are needed for patients who progress after initial treatment, the agency emphasized.
The EMA panel, the Committee for Medicinal Products for Human Use (CHMP), reviewed elotuzumab under the agency's accelerated assessment program because the drug addresses an unmet medical need. The CHMP opinion will now be sent to the European Commission for a final decision on marketing authorization for the European Union.
Because multiple myeloma is rare, elotuzumab also received an orphan designation from the EMA Committee for Orphan Medicinal Products in 2012, which provides the company with various benefits and incentives.
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Cite this: EU Panel Likes Elotuzumab, New Approach for Multiple Myeloma - Medscape - Jan 29, 2016.
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