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News on May 28, 2021 /bioon.
com" target="_blank">/ --Nanjing Legend Biotech recently announced that the U.
S.
Food and Drug Administration (FDA) has accepted the BCMA CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel, formerly known as JNJ-4528/LCAR-B38M, LCAR- B38M CAR-T cell autologous reinfusion preparation ) and granted priority review for the biological product license application (BLA), which is used to treat adult patients with relapsed or refractory multiple myeloma (RRMM).
The FDA has set the target date for the Prescription Drug User Fee Act (PDUFA) as November 29, 2021.
In December 2019, the bioon.
com/fda/" target="_blank">FDA granted cilta-cel breakthrough drug designation (BTD).
In April this year, the marketing authorization application (MAA) of cilta-cel was submitted to the European Medicines Agency (EMA), and the EMA has previously granted it the qualification for accelerated evaluation.
bioon.com" target="_blank">/ --Nanjing Legend Biotech recently announced that the U.
S.
Food and Drug Administration (FDA) has accepted the BCMA CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel, formerly known as JNJ-4528/LCAR-B38M, LCAR- B38M CAR-T cell autologous reinfusion preparation ) and granted priority review for the biological product license application (BLA), which is used to treat adult patients with relapsed or refractory multiple myeloma (RRMM).
The FDA has set the target date for the Prescription Drug User Fee Act (PDUFA) as November 29, 2021.
In December 2019, the bioon.
com/fda/" target="_blank">FDA granted cilta-cel breakthrough drug designation (BTD).
In April this year, the marketing authorization application (MAA) of cilta-cel was submitted to the European Medicines Agency (EMA), and the EMA has previously granted it the qualification for accelerated evaluation.
com" target="_blank">LCAR-B38M CAR-T cell autologous reinfusion preparation bioon.
com/fda/" target="_blank">FDA
Dr.
Ying Huang, CEO and CFO of Nanjing Legend Biotechnology, said: “Based on the research data reported so far, cilta-cel has shown great promise in multiple myeloma patients who have previously received multiple therapies.
Today’s The priority review marks another milestone for cilta-cel.
We look forward to continuing to work with Janssen and working with the bioon.
com/fda/" target="_blank">FDA to bring this transformative therapy to patients who need new treatment options.
"
bioon.Ying Huang, CEO and CFO of Nanjing Legend Biotechnology, said: “Based on the research data reported so far, cilta-cel has shown great promise in multiple myeloma patients who have previously received multiple therapies.
Today’s The priority review marks another milestone for cilta-cel.
We look forward to continuing to work with Janssen and working with the bioon.
com/fda/" target="_blank">FDA to bring this transformative therapy to patients who need new treatment options.
"
com/fda/" target="_blank">FDA
cilta-cel is a B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy for the treatment of relapsed or refractory multiple myeloma (RRMM).
cilta-cel is an autologous CAR-T therapy in which the patient's own T cells are reprogrammed to target and eradicate cancer.
cilta-cel is a B cell maturation antigen (BCMA) directed chimeric antigen receptor T cell (CAR-T) therapycilta-cel is an autologous CAR-T therapy in which the patient's own T cells are reprogrammed to target and eradicate cancer.
cilta-cel is a unique and structurally differentiated CAR-T cell therapy.
It contains a 4-1BB costimulatory domain and two BCMA targeting single domain antibodies.
It has a preferential expansion of CD8+ T cells Characteristics.
CAR-T cells are an innovative way to eliminate cancer cells by using the power of the patient's bioon.
com/tags/%E8%87%AA%E8%BA%AB%E5%85%8D%E7%96%AB/">own immune system.
BCMA is a protein highly expressed on myeloma cells.
bioon. It contains a 4-1BB costimulatory domain and two BCMA targeting single domain antibodies.
It has a preferential expansion of CD8+ T cells Characteristics.
CAR-T cells are an innovative way to eliminate cancer cells by using the power of the patient's bioon.
com/tags/%E8%87%AA%E8%BA%AB%E5%85%8D%E7%96%AB/">own immune system.
BCMA is a protein highly expressed on myeloma cells.
com/tags/%E8%87%AA%E8%BA%AB%E5%85%8D%E7%96%AB/">self-immune
The cilta-cel was designed and developed by Nanjing Legend Biotech, a subsidiary of Genscript.
In December 2017, Johnson & Johnson's Janssen Biotechnology and Nanjing Legend signed an exclusive global licensing and cooperation agreement to develop and commercialize cilta-cel.
In the United States, the bioon.
com/fda/" target="_blank" >FDA granted cilta-cel breakthrough drug designation in December 2019 and orphan drug designation in February 2019.
In the European Union, the European Commission (EC) granted cilta-cel orphan drug designation in February 2020 and priority drug designation (PRIME) in April 2019.
In China, the State Food and Drug Administration granted cilta-cel breakthrough drug designation (BTD) in August 2020.
bioon. In December 2017, Johnson & Johnson's Janssen Biotechnology and Nanjing Legend signed an exclusive global licensing and cooperation agreement to develop and commercialize cilta-cel.
In the United States, the bioon.
com/fda/" target="_blank" >FDA granted cilta-cel breakthrough drug designation in December 2019 and orphan drug designation in February 2019.
In the European Union, the European Commission (EC) granted cilta-cel orphan drug designation in February 2020 and priority drug designation (PRIME) in April 2019.
In China, the State Food and Drug Administration granted cilta-cel breakthrough drug designation (BTD) in August 2020.
com/fda/" target="_blank" >The FDA is in China, and the State Food and Drug Administration granted cilta-cel breakthrough drug designation (BTD) in August 2020.
cilta-cel structure characteristics
Both cilta-cel BLA and MAA are based on data from the Ib/II CARTITUDE-1 study (NCT03548207).
This is an ongoing phase Ib/II, open-label, multicenter study that is evaluating the efficacy and safety of cilta-cel in the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).
The study enrolled 97 patients.
The median number of therapies previously received by these patients was 6 (range: 3-18), 88% (n=85) were triple refractory, and 42% (n=41) were five Severe and refractory, 99% (n=96) are ineffective to the last therapy.
In this study, cilta-cel was successfully prepared for all patients.
The main purpose of the Phase Ib part of the study is to determine the safety and dosage of cilta-cel.
The phase II part will evaluate the efficacy of cilta-cel, and the primary endpoint is the overall response rate (ORR).
This is an ongoing phase Ib/II, open-label, multicenter study that is evaluating the efficacy and safety of cilta-cel in the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).
The study enrolled 97 patients.
The median number of therapies previously received by these patients was 6 (range: 3-18), 88% (n=85) were triple refractory, and 42% (n=41) were five Severe and refractory, 99% (n=96) are ineffective to the last therapy.
In this study, cilta-cel was successfully prepared for all patients.
The main purpose of the Phase Ib part of the study is to determine the safety and dosage of cilta-cel.
The phase II part will evaluate the efficacy of cilta-cel, and the primary endpoint is the overall response rate (ORR).
The latest data released at the 62nd ASH Annual Meeting at the beginning of December 2020 showed that the remission deepened over time, with a median follow-up of 12.
4 months (range: 1.
5-24.
9), according to the independent review committee (IRC) assessment and determination, 97% Of patients achieved remission (ORR=97%) , including: 67% of patients achieved strict complete remission (sCR=67%) , 26% of patients achieved very good partial remission (VGPR=26%), and 4% of patients Achieve partial relief (PR=4%).
At a median follow-up of 12.
4 months, the median progression-free survival (PFS) had not yet been reached, the 12-month progression-free survival rate was 77% (95%CI: 66-84), and the 12-month overall survival rate was 89% ( 95%CI: 80-94).
In terms of safety, the incidence of cytokine syndrome (CRS) ≥3 grade is 5%, and the incidence of neurotoxicity ≥3 grade is 10%.
97% of patients achieved remission (ORR=97%) 67% of patients achieved strict complete remission (sCR=67%)4 months (range: 1.
5-24.
9), according to the independent review committee (IRC) assessment and determination, 97% Of patients achieved remission (ORR=97%) , including: 67% of patients achieved strict complete remission (sCR=67%) , 26% of patients achieved very good partial remission (VGPR=26%), and 4% of patients Achieve partial relief (PR=4%).
At a median follow-up of 12.
4 months, the median progression-free survival (PFS) had not yet been reached, the 12-month progression-free survival rate was 77% (95%CI: 66-84), and the 12-month overall survival rate was 89% ( 95%CI: 80-94).
In terms of safety, the incidence of cytokine syndrome (CRS) ≥3 grade is 5%, and the incidence of neurotoxicity ≥3 grade is 10%.
The latest long-term follow-up data of the study will be announced at the 2021 ASCO annual meeting in early June.
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Original source: US Food and Drug Administration Grants BCMA CAR-T Cilta-cel Priority Review for the Treatment for Relapsed/Refractory Multiple Myeloma
