BMS multiple myeloma BCMA CAR-T was accepted by the FDA and awarded priority review.

These patients have received at least three treatments, including immunomodulants, protease inhibitors, and anti-CD38 antibodies.
fda's PDUFA date is March 27, 2021.
, ide-cel has been recognized by the FDA for breakthrough therapies, as well as the European Medicines Agency's PRIME qualification.
multiple myeloma (MM) is the second most common hematological malignancy after non-Hodgkin's lymphoma.
recent years, despite significant advances in chemotherapy, protease inhibitors, immunomodulant salidamine derivatives and CD38 targeted antibodies, almost all patients eventually relapse.
, the demand for new drugs in this area remains urgent.
BCMA is a trans-membrane glycoprotein that belongs to the tumor necrosis group (TNF) complex super family, also known as TNFRSF17 or CD269.
BCMA is an extremely important B-cell biomarker, widely found on the surface of MM cells, is a popular immunotherapy target for MM and other hematologic malignancies, and has become the second most popular target for anti-cancer therapy after CD19.
64 products, involving 21 CAR-Ts, have been targeted at BCMA so far, according to the CPM.
of these products are developed by Chinese companies.
point out that ide-cel submitted a BLA to the FDA in March.
, however, was rejected by the FDA.
, according to a response from the FDA at the time, ide-cel's application for the listing required more data, including additional information on chemical, manufacturing and control (CMC) modules.
this time, the BLA it resubmitted in July was accepted by the FDA and qualified for priority review.
-cel regulatory filings are based on the results of the Key II KarMMa study.
karMMa study In this study, 128 cases of over-anticipation of treatment that had previously received at least 3 treatments and were ineffective against the last treatment (no response or progression of treatment within 60 days of treatment, as defined by the International Myeloma Working Group (IMWG) Patients treated (heavily pre-treated, i.e. previously treated with multiple therapies) with relapsed and incurable multiple myeloma received ide-cel at dose levels of 150-450 x 10E6 CAR plus T cells.
these patients, the median previously treated treatment was 6, and 84% of patients were difficult to treat for all three common treatments, including immunomodulants (IMiDs), protease inhibitors (PI) and anti-CD38 antibodies;
follow-up time was 13.3 months.
the study reached the primary endpoint of total mitigation rate (ORR) and the key secondary endpoint of total mitigation rate (CR).
security results are consistent with previously reported ide-cel data.
data show that the total remission rate (ORR) for all dose levels was 73%, with 33% of patients getting complete remission (CR) or severe remission (sCR).
duration (DoR) was 10.7 months, and the medium DOR in patients with CR or sCR was 19.0 months.
PFS was 8.8 months for patients with CR or sCR and 20.2 months for patients with CR or sCR.
all patients who have reached CR or sCR and can be assessed for minimum residual disease (MRD) are MRD-negative.
the benefits of consistent clinical significance across subgroups, almost all subgroups had ORR of 50% or more, including elderly and high-risk patients.
total lifetime (OS) data continued to mature, with an estimated MOS of 19.4 months for all dose levels and a 12-month survival rate of 78%.
.