Articles tagged with: Elotuzumab
Press Releases»
Phase 3 trial did not meet primary endpoint of progression-free survival in patients not eligible for transplant
Princeton, NJ (Press Release) – Bristol Myers Squibb Company (NYSE: BMY) today announced topline results from ELOQUENT-1, a Phase 3, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. Both treatments were administered continuously until disease progression. At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint. The safety profile of ERd was generally consistent …
Press Releases»
- Median progression-free survival and overall response rate doubled among patients receiving EPd compared to pomalidomide and low-dose dexamethasone alone
- Second Empliciti-based combination approved in Europe for patients with relapsed and refractory multiple myeloma
Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Commission (EC) has approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. This approval is based on data from the ELOQUENT-3 trial in which EPd doubled both median progression-free survival (PFS) and …
Opinion»

Here in “Space City,” we’ve been celebrating an important milestone. It was 50 years ago when the unthinkable was accomplished, and we became a lunar people. On July 20, 1969 at 10:56 p.m., astronauts Neil Armstrong and Edwin “Buzz” Aldrin became the first men to walk on the Moon. With astronaut Michael Collins piloting the capsule, Houston Capcom monitoring the mission, and more than half a billion people watching on television, Armstrong climbed down the ladder and proclaimed: "That's one small step for a man, one giant leap for mankind."
The total mission duration …
Press Releases»
Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on a Type-II variation application for Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. The CHMP recommendation will now be reviewed by the European Commission, …
Press Releases»
- In the ELOQUENT-3 trial, treatment with Empliciti plus pomalidomide and dexamethasone (EPd) doubled median progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd)1
- Low discontinuation rates due to adverse reactions were observed with both EPd and Pd alone1
- Empliciti, when used in combination with pomalidomide and dexamethasone, can be administered once monthly after first two cycles1
Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 In ELOQUENT-3, a randomized, open-label, Phase 2 trial, EPd demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) …
Press Releases»

Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated the Company’s type II variation application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
“Given the need for new treatment …
Press Releases»
Application based on results from Phase 2 ELOQUENT-3 study
Princeton, NJ (Press Release) - Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed / refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The FDA granted the application priority review with an action date of December 27, 2018.
“This file acceptance is an important step in BMS’s ongoing efforts to advance …