BMS re-filed a listing application for CAR-T cell therapy for the treatment of multiple myeloma.

MM is a malignant plasma cell disease characterized by abnormal growth of bone marrow plasma cells, accompanied by overprogenic monoclonal immunoglobulin.
abnormal plasma cells gather in the bone marrow and form tumors in multiple bone tissues in the body.
not only do these cells fail to function properly, but the resulting antibodies can also cause the bone marrow to fail to produce healthy blood cells.
addition, patients will be accompanied by multiple bone-soluble damage, hypercalcemia, anemia, kidney damage.
although multiple myeloma currently has multiple therapies, there are still many patients who are resistant to all approved therapies, and it is important to develop innovative therapies to treat multiple myeloma.
B-cell mature antigen (BCMA) is a protein commonly expressed in cancer cells with multiple myeloma and is an important potential target for this aggressive blood cancer.
-cel can identify and bind to BCMA on the surface of multiple myeloma cells, which in turn leads to the proliferation and differentiation of CAR-T cells, which in turn kills cells expressing BCMA.
, ide-cel has been awarded a breakthrough treatment by the FDA and is recognized by the European Medicines Agency's PRIME.
the submission of the listing application is based on positive results from a key one-arm, open-label Phase 2 clinical trial called KarMMa, in which R/R MM patients who participated in the trial have received at least immunomodulation drugs (IMiD), protease inhibitors (PI), and anti-CD38 antibodies and are resistant to therapy.
94% of these patients developed resistance to CD38 antibody therapy and 84% had triple resistance.
results showed that among a total of 128 patients who were able to assess efficacy, the objective remission rate (ORR) was 73.4% and the total remission rate (CR) was 31.3%.
patients had a progress-free lifetime (PFS) of 8.6 months at a medium follow-up time of 11.3 months.
companies said they are committed to working with the FDA to quickly advance the regulatory review process.
we look forward to this application going well and bringing innovative treatment options to MM patients as soon as possible.
: Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma. Retrieved July 29, 2020, from the 2nd Bristol-Myers Squibb and bluebird bio Announce Positive Top-line Results from the Pivotal Phase 2 KarM Study of Ide-cel in Relapsed and Refractory Multiple Myeloma. Retrieved March 31, 2020, from.