Bristol Myers Squibb gets EMA validation for Idecabtagene Vicleucel, CC-486

The MAA for CC-486 is for the maintenance treatment of adult patients with acute myeloid leukemia (AML), who achieved complete remission (CR) or CR with incomplete blood count recovery (CRi), following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation.

"For patients with AML, maintaining remission remains an extremely important factor in the treatment of their disease," said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Development, Hematology, Bristol Myers Squibb. "This validation is an important step toward making CC-486 available to eligible patients in the European Union, who are in need of treatment options with the potential to decrease their risk of relapse and extend their overall survival."

Results supporting the ide-cel application came from the pivotal Phase 2 KarMMa study, which evaluated the efficacy and safety of ide-cel in heavily pre-treated patients with relapsed and refractory multiple myeloma. The study met its primary endpoint of overall response rate and key secondary endpoint of complete response rate. The safety results were consistent with previously reported data for ide-cel.

The CC-486 application is based on the efficacy and safety results of the pivotal Phase 3 QUAZAR® AML-001 study, which met the primary endpoint of improved overall survival for patients receiving AML maintenance treatment with CC-486 versus placebo.

Ide-cel and CC-486 are investigational therapies that are not approved for any indication in any geography.

Read also: Bristol Myers gets USFDA nod to Opdivo, Yervoy combo for treating Lung Cancer Patients