FDA approves Empliciti for new MM indication
BMS’ Empliciti Garners a New FDA Indication for Multiple Myeloma
By Alex Keown
There will be a new multiple myeloma treatment hitting the market soon. On Tuesday, Bristol-Myers Squibb snagged regulatory approval from the U.S. Food and Drug Administration (FDA) for Empliciti (elotuzumab) for adults with multiple myeloma who have received at least two prior therapies.
The FDA approved Empliciti, an intravenous treatment, in combination with pomalidomide and dexamethasone as the third-line medication. It was approved under priority review. Empliciti in combination with the other medications, known as EPd, will be used if other treatments including lenalidomide (Celgene’s Revlimid) and a proteasome inhibitor have failed to address a patient’s needs. Empliciti was approved based on results from the Phase II ELOQUENT-3 trial that showed the drug benefitted patients with relapsed or refractory multiple myeloma. The data showed that Empliciti doubled both median progression-free survival and overall response rate versus pomalidomide and dexamethasone.
Joseph Eid, head of medical at BMS, said Empliciti in combination with pomalidomide and dexamethasone has provided proof that the medication can extend the time a patient can live without the worsening of his or her disease. The treatment gives doctors an “effective tool” to tackle the cancer. The approval of Empliciti reinforces the important of immuno-oncology in blood cancers and expands the role of Empliciti to address the needs of relapsed or refractory multiple myeloma patients, Eid said.
Approximately 31,000 people in the United States will be diagnosed with multiple myeloma this year. One of the most common characteristics of multiple myeloma is the number of relapses patients can experience – in other words, the cancer returns after a period of remission.
In the Phase II trial, Empliciti combined with the other two medications, reduced the risk of disease progression by 46 percent. That translated into a median progression-free survival of 10.25 months. For overall survival, which was a secondary endpoint, BMS said response rates doubled in patients who received the triple combination EPd compared to patients who received pomalidomide and dexamethasone alone, 53 percent to 26 percent respectively.
The approval of BMS’ Empliciti does not come without some safety concerns. BMS said serious adverse reactions were reported in 22 percent of patients treated with EPd and in 15 percent of patients treated with pomalidomide and dexamethasone. Discontinuation of any component of the treatment regimen due to adverse reactions occurred in 5 percent of patients in the EPd arm, compared to 1.8 percent of patients in the control arm. As a result of those adverse events, FDA approval does come with warnings and precautions related to infusion reactions, infections, secondary primary malignancies, hepatotoxicity and interference with determination of complete response. There are also some warnings regarding reproductive potential in both males and females, BMS said.
Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.
Paul Richardson, director of clinical research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said despite all the novel therapies that have been developed for multiple myeloma, many patients still face poor outcomes. Those outcomes can become worse in the relapsed and relapsed, refractory setting, he said.
“This new regimen of elotuzumab combined with pomalidomide and dexamethasone not only extended the time to disease progression versus a standard of care but also doubled the response rate in some patients whose prior treatments had failed them. Thus to be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients,” Paulson said in a statement.