-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
▎The content team editor of WuXi AppTec recently, a proteasome inhibitor, carfilzomib for injection (carfilzomib, trade name: Kyprolis), was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of relapse or Refractory multiple myeloma (MM) brings new treatment options and hope for patients
.
Screenshot source: Multiple myeloma, an incurable disease on the NMPA official website, is a malignant disease caused by the abnormal proliferation of clonal plasma cells.
It is the second most common malignant tumor in the blood system, accounting for about 10% of hematological malignancies
.
The 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
.
Although multiple myeloma is still incurable, with proteasome inhibitors, immunomodulators, anti-CD38 monoclonal antibodies, CAR-T cell therapy, autologous hematopoietic stem cell transplantation and other treatments, as well as the application of combined treatment programs, it is more common The treatment of sexual myeloma has been improved and improved, and the patient’s survival period has been significantly prolonged
.
However, most patients with multiple myeloma will eventually relapse or refractory (drug resistance) after treatment, and the treatment options for patients with relapsed or refractory multiple myeloma are more limited, and their treatment still faces great challenges
.
The second-generation proteasome inhibitor "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (Revised in 2020)" pointed out that proteasome inhibitors and immunomodulators are the cornerstones of multiple myeloma treatment options and run through the entire treatment of multiple myeloma.
Process
.
The proteasome in human cells can break down damaged or no longer needed proteins.
It plays an important role in the normal function and growth of cells
.
However, in multiple myeloma, the activity of the proteasome may usually be enhanced and drive tumor progression through many key processes
.
Carfilzomib is a second-generation proteasome inhibitor.
Its mechanism of action is to block the function of proteasome in cancer cells to decompose proteins, so that the protein in cancer cells will over-accumulate, which will eventually be overwhelmed, collapse and die
.
Because myeloma cells contain a large amount of abnormal proteins, the effect of carfilzomib on the death of myeloma cells is particularly obvious
.
In recent years, the multi-drug combination regimen based on carfilzomib has played an important role in the treatment of multiple myeloma
.
In 2016, Carfilzomib was approved by the US FDA as a monotherapy or combined with dexamethasone or dexamethasone + lenalidomide to treat relapsed or refractory multiples Patients with myeloma
.
At the same time, Carfilzomi has also been approved for listing in Australia, Canada, Hong Kong, Japan, South Korea, Switzerland, Russia and other countries and regions
.
Image source: 123RF significantly prolonged patient survival.
In a phase 3 clinical trial called ASPIRE, 792 patients with relapsed or refractory multiple myeloma received carfilzomib in combination with lenalidomide and dexamethasone ( KRd) combination regimen or lenalidomide and dexamethasone (Rd) regimen
.
These patients have previously been treated with 1-3 other therapies
.
The test results show that the addition of carfilzomib to the Rd program can further improve the progression-free survival (PFS) and overall survival (OS) of patients with relapsed or refractory multiple myeloma.
The KRd program group The efficacy is better; and in terms of safety, the KRd regimen group has no significant increase in toxicity compared with the Rd regimen group
.
In terms of progression-free survival, the median progression-free survival of patients in the KRd group was 26.
1 months, which was significantly higher than 16.
6 months in the Rd group; the 3-year and 5-year progression-free survival rates of patients in the KRd group were 38.
2% and 25.
6%, respectively , Significantly higher than the 28.
4% and 17.
3% of patients in the Rd group
.
In terms of overall survival, the median overall survival of patients in the KRd group was 48.
3 months, while that of the Rd group was 40.
3 months
.
In addition, a subgroup analysis of the overall survival time revealed that the median overall survival time of patients with relapsed or refractory multiple myeloma who had received one treatment in the past was 47.
3 months (KRd group) and 35.
9 months (Rd group), respectively.
; For patients who have received 2 or more treatments in the past, the median overall survival was 48.
8 months (KRd group) and 42.
3 months (Rd group)
.
In terms of safety, 19.
9% of patients in the KRd group discontinued treatment due to adverse events, while the rate in the Rd group was 21.
5%
.
In terms of the incidence of adverse events of grade ≥3, 87% in the KRd group and 83.
3% in the Rd group.
The incidence of acute renal failure was 3.
8% (KRd group) and 3.
3% (Rd group), respectively.
Heart failure occurred The rates were 4.
3% (KRd group) and 2.
1% (Rd group), and the incidence of hypertension was 6.
4% (KRd group) and 2.
3% (Rd group)
.
Researchers in the ASPIRE trial said that the combination of three drugs with different mechanisms of action is a better choice than the two-drug combination regimen.
The KRd regimen can be used as an effective treatment regimen for patients with relapsed or refractory multiple myeloma.
.
We look forward to the benefits of more multiple myeloma patients with the approval of carfilzomib in China
.
Recommended reading: New options for the treatment of primary hypercholesterolemia.
Haibo Mebu tablets have been approved for marketing to fight AIDS, and a new generation of non-nucleoside reverse transcriptase inhibitors have been approved for marketing.
Patients with non-small cell lung cancer ushered in the first MET inhibitor.
The disease control rate is as high as 93.
4%.
First-line immunotherapy for liver cancer is approved! Significantly prolong the survival time of Chinese liver cancer patients, a disease that affects tens of millions of Chinese people, ushering in new treatment methods reference materials [1] Chinese Medical Doctor Association Hematologists Branch, et al.
, (2020).
China Multiple Bone Marrow Tumor diagnosis and treatment guidelines (revised in 2020).
Chinese Journal of Internal Medicine, DOI: 10.
3760/cma.
j.
cn112138-20200304-00179.
[2] David S.
Siegel, et al.
,(2018).
Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma.
Journal of Clinical Oncology, DOI: 10.
1200/JCO.
2017.
76.
5032.
[3] July 08, 2021, the information of drug approval documents to be received is released.
Retrieved Jul 8, 2021, from https:// Amgen (AMGN) Release: Second Phase III Study Shows Kyprolis (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma.
Retrieved Jul 8, 2021, from https://
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
.
Screenshot source: Multiple myeloma, an incurable disease on the NMPA official website, is a malignant disease caused by the abnormal proliferation of clonal plasma cells.
It is the second most common malignant tumor in the blood system, accounting for about 10% of hematological malignancies
.
The 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
.
Although multiple myeloma is still incurable, with proteasome inhibitors, immunomodulators, anti-CD38 monoclonal antibodies, CAR-T cell therapy, autologous hematopoietic stem cell transplantation and other treatments, as well as the application of combined treatment programs, it is more common The treatment of sexual myeloma has been improved and improved, and the patient’s survival period has been significantly prolonged
.
However, most patients with multiple myeloma will eventually relapse or refractory (drug resistance) after treatment, and the treatment options for patients with relapsed or refractory multiple myeloma are more limited, and their treatment still faces great challenges
.
The second-generation proteasome inhibitor "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (Revised in 2020)" pointed out that proteasome inhibitors and immunomodulators are the cornerstones of multiple myeloma treatment options and run through the entire treatment of multiple myeloma.
Process
.
The proteasome in human cells can break down damaged or no longer needed proteins.
It plays an important role in the normal function and growth of cells
.
However, in multiple myeloma, the activity of the proteasome may usually be enhanced and drive tumor progression through many key processes
.
Carfilzomib is a second-generation proteasome inhibitor.
Its mechanism of action is to block the function of proteasome in cancer cells to decompose proteins, so that the protein in cancer cells will over-accumulate, which will eventually be overwhelmed, collapse and die
.
Because myeloma cells contain a large amount of abnormal proteins, the effect of carfilzomib on the death of myeloma cells is particularly obvious
.
In recent years, the multi-drug combination regimen based on carfilzomib has played an important role in the treatment of multiple myeloma
.
In 2016, Carfilzomib was approved by the US FDA as a monotherapy or combined with dexamethasone or dexamethasone + lenalidomide to treat relapsed or refractory multiples Patients with myeloma
.
At the same time, Carfilzomi has also been approved for listing in Australia, Canada, Hong Kong, Japan, South Korea, Switzerland, Russia and other countries and regions
.
Image source: 123RF significantly prolonged patient survival.
In a phase 3 clinical trial called ASPIRE, 792 patients with relapsed or refractory multiple myeloma received carfilzomib in combination with lenalidomide and dexamethasone ( KRd) combination regimen or lenalidomide and dexamethasone (Rd) regimen
.
These patients have previously been treated with 1-3 other therapies
.
The test results show that the addition of carfilzomib to the Rd program can further improve the progression-free survival (PFS) and overall survival (OS) of patients with relapsed or refractory multiple myeloma.
The KRd program group The efficacy is better; and in terms of safety, the KRd regimen group has no significant increase in toxicity compared with the Rd regimen group
.
In terms of progression-free survival, the median progression-free survival of patients in the KRd group was 26.
1 months, which was significantly higher than 16.
6 months in the Rd group; the 3-year and 5-year progression-free survival rates of patients in the KRd group were 38.
2% and 25.
6%, respectively , Significantly higher than the 28.
4% and 17.
3% of patients in the Rd group
.
In terms of overall survival, the median overall survival of patients in the KRd group was 48.
3 months, while that of the Rd group was 40.
3 months
.
In addition, a subgroup analysis of the overall survival time revealed that the median overall survival time of patients with relapsed or refractory multiple myeloma who had received one treatment in the past was 47.
3 months (KRd group) and 35.
9 months (Rd group), respectively.
; For patients who have received 2 or more treatments in the past, the median overall survival was 48.
8 months (KRd group) and 42.
3 months (Rd group)
.
In terms of safety, 19.
9% of patients in the KRd group discontinued treatment due to adverse events, while the rate in the Rd group was 21.
5%
.
In terms of the incidence of adverse events of grade ≥3, 87% in the KRd group and 83.
3% in the Rd group.
The incidence of acute renal failure was 3.
8% (KRd group) and 3.
3% (Rd group), respectively.
Heart failure occurred The rates were 4.
3% (KRd group) and 2.
1% (Rd group), and the incidence of hypertension was 6.
4% (KRd group) and 2.
3% (Rd group)
.
Researchers in the ASPIRE trial said that the combination of three drugs with different mechanisms of action is a better choice than the two-drug combination regimen.
The KRd regimen can be used as an effective treatment regimen for patients with relapsed or refractory multiple myeloma.
.
We look forward to the benefits of more multiple myeloma patients with the approval of carfilzomib in China
.
Recommended reading: New options for the treatment of primary hypercholesterolemia.
Haibo Mebu tablets have been approved for marketing to fight AIDS, and a new generation of non-nucleoside reverse transcriptase inhibitors have been approved for marketing.
Patients with non-small cell lung cancer ushered in the first MET inhibitor.
The disease control rate is as high as 93.
4%.
First-line immunotherapy for liver cancer is approved! Significantly prolong the survival time of Chinese liver cancer patients, a disease that affects tens of millions of Chinese people, ushering in new treatment methods reference materials [1] Chinese Medical Doctor Association Hematologists Branch, et al.
, (2020).
China Multiple Bone Marrow Tumor diagnosis and treatment guidelines (revised in 2020).
Chinese Journal of Internal Medicine, DOI: 10.
3760/cma.
j.
cn112138-20200304-00179.
[2] David S.
Siegel, et al.
,(2018).
Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma.
Journal of Clinical Oncology, DOI: 10.
1200/JCO.
2017.
76.
5032.
[3] July 08, 2021, the information of drug approval documents to be received is released.
Retrieved Jul 8, 2021, from https:// Amgen (AMGN) Release: Second Phase III Study Shows Kyprolis (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma.
Retrieved Jul 8, 2021, from https://
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
