BCMA CAR-T Cell Therapy! Johnson/Nanjing Legend cilta-cel awarded an accelerated assessment by the European Union: Treatment of multiple myeloma!

February 02, 2021 // -- Johnson and Johnson (JNJ)'s Janssen Pharmaceuticals recently announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) will accelerate the evaluation of the marketing authorization application (MAA) for BCM CAR-T cell therapy cilta-tag autoneucel (cilta-cel), formerly known as JNJ-4528/LCAR-B38M.
when a drug is expected to have significant public health benefits and therapeutic innovations, CHMP will grant accelerated assessments, which will significantly shorten the MAA review time.
expected cilta-cel MAA to be submitted in the first half of 2021.
December 2020, Janssen Pharmaceuticals has initiated a rolling submission of cilta-cel's Biological Products Licensing Application (BLA) to the FDA.
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 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).
CAR-T therapy is a highly individualized technique in which patients' own T-cells are reprogrammed to target and eradicate cancer.
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 features cilta-cel BLA and MAA 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 relapsed 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) 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 at the 62nd ANNUAL ASH Meeting in early December 2020 continues to show that mitigation deepens over time, with a medium follow-up of 12.4 months (range: 1.5-24.9), according to the Independent Review Board (IRC) assessment, Ninety-seven percent of patients achieved remission (ORR-97%), including: 67% achieved strict total remission (sCR-67%), 26% achieved very good partial remission (VGPR-26%), and 4% 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 Announces CAR-T Therapy Ciltacabtagene Autoleucel (Cilta-cel) Accepted for Accelerated Assessment in Europe for The Treatment of Patients with Heavily Pretreated Multiple Myeloma