The world's fifth CAR-T therapy was approved by the FDA for marketing, targeting BCMA

On March 26, 2021, Abecma (idecabtagene vicleucel; ide-cel), a CAR-T cell therapy product jointly developed by BMS (Bristol-Myers Squibb) and Bluebird (Bluebird Bio) , was officially approved for marketing by the FDA .

Previously (March 2020), BMS and Bluebird had submitted the ide-cel biological product license application (BLA) to the FDA, but in May of the same year, the FDA added additional chemical, manufacturing and control (CMC) Concerns about the module, rejected the listing request of the product, and then the two companies obtained the BLA approval in September after submitting additional information on which there were concerns.

MM is a malignant plasma cell disease characterized by abnormal proliferation of bone marrow plasma cells, accompanied by excessive production of monoclonal immunoglobulins.

B cell maturation antigen (BCMA) is a protein commonly expressed on multiple myeloma cancer cells, and it is an important potential target for this aggressive blood cancer.

The marketing approval is based on the positive results of a key single-arm, open-label phase 2 clinical trial called KarMMa.

Earlier, in November 2017 ide-cel breakthrough therapy has been FDA finds, as well as the European Medicines Management PRIME Qualification Board.

4 CAR-T cell therapies on the market

Before ide-cel was approved, four CAR-T models were approved, namely Novartis’ Kymriah, Gilead’s subsidiary Kite Pharmaceutical’s Yescarta and Tecartus, and BMS’s CAR-T cell product Liso-cel.

On August 30, 2017, the FDA approved Novartis’ CAR-T cell therapy products.

In October 2017, Gilead/Kite's CAR-T product Yescarta (Axicabtagene Ciloleucel, Axi-Cel) was approved by the US FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).

In July 2020, Gilead/Kite's CAR-T product Tecartus (brexucabtagene autoleucel, formerly KTE-X19) was approved by the US FDA for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (MCL).

In February 2021, Bristol-Myers Squibb (BMS) CAR-T cell product Liso-cel was approved by the US FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

In addition to the newly approved Liso-cel and Tecartus, the other two products have been approved/applied for listing in many countries including Europe, Japan and Canada.