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▎The content team editor of WuXi AppTec today, Janssen, a subsidiary of Johnson & Johnson, announced that it has submitted a biologics license application (BLA) for teclistamab to the US FDA for the treatment of relapsed or refractory (R/R) Patients with multiple myeloma (MM)
.
Teclistamab is an under-research "ready-to-use" T cell redirecting bispecific antibody that targets B cell maturation antigen (BCMA) and CD3 receptors on the surface of T lymphocytes
.
MM is a malignant disease caused by the abnormal proliferation of clonal plasma cells.
It is the second most common malignant tumor of the hematological system, accounting for about 10% of hematological malignancies
.
This disease mostly occurs in the elderly, and can lead to increased blood calcium, renal damage, anemia, bone disease, and secondary amyloidosis, which can be life-threatening
.
In China, the incidence of multiple myeloma is increasing year by year and getting younger.
According to the "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (Revised in 2020)", the incidence of multiple myeloma in China in 2019 was 1.
6 per 100,000.
, The death toll was 146,500
.
There is still no cure for multiple myeloma, and patients may eventually face the risk of disease recurrence, drug resistance, and even multi-drug resistance
.
BCMA is a popular target for the treatment of B-cell blood cancers and is highly expressed in multiple myeloma cells
.
Teclistamab can recruit CD3-positive T cells to the vicinity of tumor cells expressing BCMA and stimulate cytotoxicity with killing effect
.
Previously, the drug has been granted orphan drug designation and breakthrough therapy designation (BTD) by the FDA for the treatment of multiple myeloma
.
Image source: 123RF The submission of this BLA is based on the positive results of a multi-center Phase 1/2 clinical trial evaluating the efficacy and safety of teclistamab
.
The latest clinical results show that during a median follow-up of nearly 8 months, among the severely pretreated patients (n=150) who received the recommended dose (1.
5 mg/kg) of teclistamab in the phase 2 clinical trial of subcutaneous injection formulations, objective The response rate (ORR) reached 62% (n=93/150)
.
These patients have previously received at least 3 lines of treatment
.
Moreover, 58% of patients in the trial achieved very good partial remission (VGPR), and 25% of patients achieved complete remission (CR)
.
The 9-month progression-free survival rate (PFS) was 59%, which did not reach the median overall survival (OS)
.
Dr.
Peter Lebowitz, Head of Global Oncology, Janssen Research & Development, said: "Even taking into account all the advances in the clinical treatment of multiple myeloma, the unmet need is still very high
.
We look forward to cooperating with the US FDA to review teclistamab.
Relevant application documents
.
"Reference: [1] Janssen Submits Biologics License Application to US FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma.
Retrieved December 29, 2021, from https:// releases/janssen-submits-biologics-license-application-to-us-fda-seeking-approval-of-teclistamab-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-301451472.
html[2] New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma.
Retrieved December 13, 2021, from https:// /new-data-majestec-1-study-show-continued-deep-and-durable-responses-teclistamab-bcmaxcd3-bispecific Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
Teclistamab is an under-research "ready-to-use" T cell redirecting bispecific antibody that targets B cell maturation antigen (BCMA) and CD3 receptors on the surface of T lymphocytes
.
MM is a malignant disease caused by the abnormal proliferation of clonal plasma cells.
It is the second most common malignant tumor of the hematological system, accounting for about 10% of hematological malignancies
.
This disease mostly occurs in the elderly, and can lead to increased blood calcium, renal damage, anemia, bone disease, and secondary amyloidosis, which can be life-threatening
.
In China, the incidence of multiple myeloma is increasing year by year and getting younger.
According to the "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (Revised in 2020)", the incidence of multiple myeloma in China in 2019 was 1.
6 per 100,000.
, The death toll was 146,500
.
There is still no cure for multiple myeloma, and patients may eventually face the risk of disease recurrence, drug resistance, and even multi-drug resistance
.
BCMA is a popular target for the treatment of B-cell blood cancers and is highly expressed in multiple myeloma cells
.
Teclistamab can recruit CD3-positive T cells to the vicinity of tumor cells expressing BCMA and stimulate cytotoxicity with killing effect
.
Previously, the drug has been granted orphan drug designation and breakthrough therapy designation (BTD) by the FDA for the treatment of multiple myeloma
.
Image source: 123RF The submission of this BLA is based on the positive results of a multi-center Phase 1/2 clinical trial evaluating the efficacy and safety of teclistamab
.
The latest clinical results show that during a median follow-up of nearly 8 months, among the severely pretreated patients (n=150) who received the recommended dose (1.
5 mg/kg) of teclistamab in the phase 2 clinical trial of subcutaneous injection formulations, objective The response rate (ORR) reached 62% (n=93/150)
.
These patients have previously received at least 3 lines of treatment
.
Moreover, 58% of patients in the trial achieved very good partial remission (VGPR), and 25% of patients achieved complete remission (CR)
.
The 9-month progression-free survival rate (PFS) was 59%, which did not reach the median overall survival (OS)
.
Dr.
Peter Lebowitz, Head of Global Oncology, Janssen Research & Development, said: "Even taking into account all the advances in the clinical treatment of multiple myeloma, the unmet need is still very high
.
We look forward to cooperating with the US FDA to review teclistamab.
Relevant application documents
.
"Reference: [1] Janssen Submits Biologics License Application to US FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma.
Retrieved December 29, 2021, from https:// releases/janssen-submits-biologics-license-application-to-us-fda-seeking-approval-of-teclistamab-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-301451472.
html[2] New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma.
Retrieved December 13, 2021, from https:// /new-data-majestec-1-study-show-continued-deep-and-durable-responses-teclistamab-bcmaxcd3-bispecific Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
