FDA approves BMS' multiple myeloma combo after it doubles progression-free survival

The FDA has seen fit to approve Bristol-Myers Squibb’s Empliciti (elotuzumab) intravenous injection in combination with pomalidomide and dexamethasone for the treatment of multiple myeloma, it has emerged.

The approval will make the combination available to adult patients who have received at least two prior treatments for their condition, including lenalidomide and a proteasome inhibitor. The decision came off the back of Phase 2 data which showed that the therapy doubled progression-free survival (PFS) and overall response rate (ORR) compared to pomalidomide and dexamethasone alone in relapsed or refractory multiple myeloma. The condition sees around 31,000 new diagnoses in the US each year.

“Despite remarkable recent innovations with novel therapies for the treatment of multiple myeloma, many patients still face poor outcomes, and particularly in the relapsed and relapsed, refractory setting,” said Dr Paul Richardson, Clinical Program Leader and Director of Clinical Research of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute. “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.”

Dr Joseph E Eid, Senior Vice President and Head of Medical at Bristol-Myers Squibb, also remarked: “Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving health care professionals an effective new tool to tackle this relentless cancer. Today’s approval reinforces the importance of Immuno-Oncology in blood cancers and expands the role of Empliciti to address the needs of relapsed or refractory multiple myeloma patients.”

Matt Fellows