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News from June 02, 2021 // --Jansen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that the U.
S.
Food and Drug Administration ( FDA ) has granted a universal T cell redirection BCMxCD3 bispecific antibody teclistamab (JNJ-64007957, JNJ-7957) for the treatment of relapsed or refractory Breakthrough Drug Qualification (BTD) for multiple myeloma (MM).
It is worth mentioning that this is the 11th BTD harvested by Johnson & Johnson in the field of oncology .
Earlier this year, the European Medicines Agency (EMA) granted teclistamab Priority Drug Designation (PRIME).
FDA universal T cell redirection BCMAxCD3 bispecific antibody teclistamab Johnson in cancer field of harvest of 11 BTD tumorsS.
Food and Drug Administration ( FDA ) has granted a universal T cell redirection BCMxCD3 bispecific antibody teclistamab (JNJ-64007957, JNJ-7957) for the treatment of relapsed or refractory Breakthrough Drug Qualification (BTD) for multiple myeloma (MM).
It is worth mentioning that this is the 11th BTD harvested by Johnson & Johnson in the field of oncology .
Earlier this year, the European Medicines Agency (EMA) granted teclistamab Priority Drug Designation (PRIME).
BTD is a new drug review channel of the FDA, which aims to accelerate the development and review of new drugs for the treatment of serious or life-threatening diseases, and there is preliminary clinical evidence that compared with existing treatment drugs, new drugs that can substantially improve the condition of the disease.
BTD-obtained drugs can receive closer guidance including high-level FDA officials during development , ensuring that new treatment options are provided to patients in the shortest possible time.
FDABTD-obtained drugs can receive closer guidance including high-level FDA officials during development , ensuring that new treatment options are provided to patients in the shortest possible time.
PRIME is similar to BTD.
This is a rapid review project launched by EMA in March 2016 to accelerate the review process of key drugs in the field of medical shortages.
Drugs that are shortlisted for PRIME will receive strong support from EMA in clinical trials and development.
, In order to accelerate the development and approval of truly innovative drugs to meet the medical needs for promising new drugs.
Clinical TrialsThis is a rapid review project launched by EMA in March 2016 to accelerate the review process of key drugs in the field of medical shortages.
Drugs that are shortlisted for PRIME will receive strong support from EMA in clinical trials and development.
, In order to accelerate the development and approval of truly innovative drugs to meet the medical needs for promising new drugs.
Dr.
Peter Lebowitz, Head of Global Oncology Therapy of Janssen R&D , said: “We are very pleased that the new bispecific antibody teclistamab has obtained BTD and PRIME qualifications.
This project reflects our commitment to advance scientific research in multiple myeloma.
Built on our strong investment portfolio for this disease.
"
TumorPeter Lebowitz, Head of Global Oncology Therapy of Janssen R&D , said: “We are very pleased that the new bispecific antibody teclistamab has obtained BTD and PRIME qualifications.
This project reflects our commitment to advance scientific research in multiple myeloma.
Built on our strong investment portfolio for this disease.
"
teclistamab mechanism of action
teclistamab is a bispecific antibody targeting B cell maturation antigen (BCMA) and T cell CD3 receptor.
The expression level of BCMA on multiple myeloma cells is significantly increased, and CD3 is involved in activating T cells.
teclistamab redirects CD3 T cells to BCMA-expressing myeloma cells to induce cytotoxicity against target cells.
The results of preclinical studies have shown that teclistamab can kill myeloma cells from over-pretreated patients.
teclistamab is a bispecific antibody targeting B cell maturation antigen (BCMA) and T cell CD3 receptor.The expression level of BCMA on multiple myeloma cells is significantly increased, and CD3 is involved in activating T cells.
teclistamab redirects CD3 T cells to BCMA-expressing myeloma cells to induce cytotoxicity against target cells.
The results of preclinical studies have shown that teclistamab can kill myeloma cells from over-pretreated patients.
Currently, teclistamab is evaluating the efficacy of treating relapsed or refractory multiple myeloma (RRMM) in a phase I clinical study, and is also exploring in a joint study.
The production and development of teclistamab follows the license agreement signed by Janssen Biotechnology and Genmab to use the DuoBody® technology platform.
The production and development of teclistamab follows the license agreement signed by Janssen Biotechnology and Genmab to use the DuoBody® technology platform.
The FDA granted teclistamab BTD based on the results of the Phase I MajesTEC-1 study (NCT03145181).
This is the first human dose escalation study to evaluate teclistamab, and it is carried out in patients with relapsed or refractory multiple myeloma (RRMM) who have previously received multiple regimens (heavily-pretreated).
FDAThis is the first human dose escalation study to evaluate teclistamab, and it is carried out in patients with relapsed or refractory multiple myeloma (RRMM) who have previously received multiple regimens (heavily-pretreated).
The recently published results of subcutaneous preparations (SC) showed that a median follow-up of 6 months, in a cohort of overpretreatment patients who had previously received a median of 5 therapies (n=40), the recommended phase 2 dose (RP2D) ), the overall response rate (ORR) of teclistamab treatment was 65% (n=26/40), the very good partial response (VGPR) or better response rate was 58%, and the complete response rate (CR) was 40%.
The median time from treatment to first remission is 1 month, and the median duration of remission (DOR) has not yet been reached.
Over time, profound, lasting relief was observed.
At the same time, teclistamab subcutaneous preparations show controllable safety.
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The overall response rate (ORR) of teclistamab treatment was 65% (n=26/40), the very good partial response (VGPR) or better response rate was 58%, and the complete response rate (CR) was 40%.The median time from treatment to first remission is 1 month, and the median duration of remission (DOR) has not yet been reached.
Over time, profound, lasting relief was observed.
At the same time, teclistamab subcutaneous preparations show controllable safety.
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Original source: Janssen Announces US FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
FDA 
