Bristol-Myers Squibb Co. filed an application with the U.S. Food and Drug Administration for the approval of its chimeric antigen receptor T cell therapy, dubbed liso-cel, to treat certain blood cancer patients.
The company's biologics license application seeks approval for liso-cel, or lisocabtagene maraleucel, to treat patients with large B-cell lymphoma, or LBCL, who have received at least two prior therapies and their disease either returned or did not respond to therapy.
Bristol-Myers' biologics license application is backed by data from the Transcend NHL 001 study, which evaluated the therapy in 269 patients with LBCL, including diffuse large B-cell lymphoma, or DLBCL.
The company presented results from multiple studies evaluating liso-cel at the 2019 American Society of Hematology's annual meeting earlier in December, with the results showing that a majority of patients responded to the therapy.
Bristol-Myers inherited liso-cel, which is yet to be approved for marketing in any country, after the $95 billion acquisition of Celgene Corp. If approved, liso-cel will compete with Yescarta from Gilead Sciences Inc. and Novartis AG's Kymriah, which are already approved.
Liso-cel has received multiple designations from the FDA, including breakthrough therapy and regenerative medicine advanced therapy designations for relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma, including DLBCL; primary mediastinal B-cell lymphoma; or Grade 3B follicular lymphoma.
The therapy is also in the European Medicines Agency's priority medicines scheme for relapsed/refractory DLBCL.