BCMA CAR-T Cell Therapy! Johnson/Nanjing Legend cilta-cel submits rolling listing application in the United States: Treatment of multiple myeloma!

December 24, 2020 // -- Johnson and Johnson (JNJ)'s Jansen Pharmaceuticals recently announced that it has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of cilta-cel, formerly known as JNJ-4528/LCAR-B38M, for biological product licensing applications (BLA).
cilta-cel is a developed B-cell mature antigen (BCMA)-oriented chimic antigen-subject T-cell (CAR-T) therapy for the treatment of recurring or refractic multiple myeloma (RRMM).
note that this is Johnson and Johnson's first application for cell therapy.
, the FDA has granted cilta-cel breakthrough drug eligibility (BTD) and agreed to a rolling review of the BLA.
cilta-cel is a unique, structurally differentiated CAR-T cell therapy that contains a 4-1BB costulation domain and two BCMA targeted monometric antibodies, with a CD8-T cell-preferred amplification feature.
CAR-T cells are an innovative way to kill cancer cells by harnessing the power of the patient's own immune system.
BCMA is a highly expressed protein on myeloma cells.
cel was designed and developed by Legend Biotech of Nanjing, a subsidiary of Genscript.
December 2017, Johnson and Johnson's Janssen Biotech signed an exclusive global license and cooperation agreement with Nanjing Legend to develop and commercialize cilta-cel.
U.S., the FDA granted cilta-cel breakthrough drug eligibility in December 2019 and orphan drug eligibility in February 2019.
in the European Union, the European Commission (EC) granted JNJ-4528 orphan drug eligibility in February 2020 and priority drug eligibility (PRIME) in April 2019.
in China, the State Drug Administration granted cilta-cel breakthrough drug eligibility (BTD) in August 2020.
December 2017, Jansen signed an exclusive global license and cooperation agreement with Legend Biotech nanjing to develop and commercialize JNJ-4528 (LCAR-B38M).
May 2018, based on the results of the LEGEND-2 study, Jansen initiated a Phase IB/II trial (NCT03548207) to assess the efficacy and safety of JNJ-4528's treatment of recurring or refracectable multiple myeloma in adults.
cilta-cel structural characteristics cilta-cel BLA based on IB/II CARTITUDE-1 study (NCT03548207) data.
this is an ongoing Ib/II, open label, multi-center study that is evaluating the efficacy and safety of cilta-cel treatment for adult patients with recurring or refractic multiple myeloma (RRMM).
the study included 97 patients who had previously received a median of 6 treatments (range: 3-18), 88% (n-85) triple-difficult, 42% (n-41) five-difficult, and 99% (n-96) that were ineffective for the last treatment.
the study, cilta-cel was successfully prepared for all patients.
the IB phase of the study was primarily aimed at determining the safety and dosage of cilta-cel.
Phase II will evaluate the efficacy of cilta-cel, with the main endpoints of which are total remission rate (ORR).
data released earlier this month at the 62nd annual ASH meeting continued to show that mitigation deepened over time, with a mid-range follow-up of 12.4 months (range: 1.5-24.9), which, according to the Independent Review Commission (IRC) assessment, was 97 per cent Patients achieved remission (ORR=97%), including: 67% of patients achieved strict total remission (sCR=67%), 26% of patients achieved very good partial remission (VGPR=26%), and 4% of patients achieved partial remission (PR=4%).
12.4 months of medium follow-up, the medium progress-free survival period (PFS) had not yet been achieved, and the 12-month progress-free survival rate was 77% (95% CI:66-84) and the 12-month total survival rate was 89% (95% CI:80-94).
safety, the ≥ of level 3 cytokine syndrome (CRS) was 5% and the ≥ risk of neurotoxicity was 10%.
() Origin: Janssen Initiates Rolling Submission of a Biologics License application U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for The Treatment of Relapsed and/or Refractory Multiple Myeloma