This article is more than 5 years old. Information may no longer be current.
FDA grants fast track designation to CMD-003 for lymphoma, posttransplant lymphoproliferative disease
Click Here to Manage Email Alerts
The FDA granted fast track designation to CMD-003 for the treatment of patients with relapsed/refractory lymphoma and posttransplant lymphoproliferative disease associated with the oncogenic Epstein Barr virus, according to the agent’s manufacturer.
CMD-003 (Cell Medica), also known as baltaleucel-T, is an investigational therapy that consists of patients’ T cells. The T cells are activated to kill malignant cells that express Epstein Barr virus antigens.
“The fast track designation supports the potential for CMD-003 to address an important area of high unmet clinical need,” Kurt Gunter, MD, FASCP, chief medical officer of Cell Medica, said in a company-issued press release. “The potential eligibility for accelerated approval and priority biologics license application review will help facilitate the development of our lead cancer immunotherapy candidate. We are committed to bringing this novel treatment to patients as soon as possible.”
Cell Medica initiated two trials designed to evaluate CMD-003 in various patient populations.
The international, open-label, phase 2 CITADEL trial will assess the agent as treatment for extranodal natural killer T cell lymphoma.
The phase 2 CIVIC trial includes patients with Epstein Barr virus–associated diffuse large B-cell lymphoma, Hodgkin lymphoma and posttransplant lymphoproliferative disease.