Bristol-Myers Squibb Announces Opening of Expanded Access Program for Elotuzumab

Bristol-Myers Squibb (BMS) has opened an expanded access protocol for its monoclonal antibody elotuzumab in combination with Revlimid® and dexamethasone. Expanded access is a process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. ?While data from a large, phase III randomized trial comparing elotuzumab plus Rev/dex versus Rev/dex alone is eagerly anticipated, in the interim patients may now enroll at an available site for access to this new combination therapy. The first 5 of a planned 50-60 sites are now enrolling patients with myeloma that has relapsed after 1-3 prior treatments. For eligibility criteria and site information CLICK HERE.
Source: International Myeloma Foundation - Category: Hematology Source Type: news