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▎The content team editor of WuXi AppTec recently, a new oral anticancer drug, selinexor (trade name: Xivio), was approved for marketing by the National Medical Products Administration (NMPA).
Combination of dexamethasone to treat relapsed or refractory multiple myeloma (RRMM) that has been previously treated and is refractory to at least one proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody
.
”
The approval of this drug in China is expected to bring new treatment options and hope for patients with relapsed or refractory multiple myeloma
.
Screenshot source: NMPA's official website.
Multiple myeloma (MM), the second-largest malignant tumor of the blood system, 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 approximately the blood system 10% of malignant tumors
.
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 the age of patients is showing a younger trend
.
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, and the number of deaths was 146,554
.
In recent years, with the development of proteasome inhibitors, immunomodulators, anti-CD38 monoclonal antibodies, CAR-T cell therapy, autologous hematopoietic stem cell transplantation and other therapeutic methods, as well as the application of combined treatment programs, the treatment of multiple myeloma It has been perfected and improved, and the patient's survival period has been significantly prolonged
.
However, 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 (that is, resistance to existing drugs)
.
For patients with relapse or drug resistance, the goal of treatment is to relieve the disease to the greatest extent, extend the progression-free survival period, and improve the quality of life
.
Image source: 123RF's first XPO1 inhibitor approved by the FDA According to public information, Celiniso is currently the first and only oral nuclear export protein 1 approved by the U.
S.
Food and Drug Administration (FDA) (XPO1) inhibitor is also the first drug that can be used to treat multiple myeloma and diffuse large B-cell lymphoma
.
In healthy people, oncogenes and tumor suppressor genes are in dynamic balance, while cancer patients have stronger expression of oncogenes and weaker expression of tumor suppressor genes
.
If the activity of oncogenes is inhibited, it is possible to inhibit the proliferation signal of tumor cells, and then cause tumor cells to undergo apoptosis
.
Nuclear export protein 1 (XPO1), also known as chromosomal region stabilizing protein 1, plays a vital role in maintaining cell homeostasis
.
The disorder of this protein plays a key role in the development of various solid tumors and hematological malignancies, and is highly expressed in tumor cells
.
Celiniso can promote the nuclear storage and activation of tumor suppressor protein and other growth regulatory proteins by inhibiting XPO1, and can reduce the level of a variety of oncogenic proteins in the cytoplasm, thereby arresting the tumor cell cycle and inducing tumor cell apoptosis , And normal cells are not affected
.
Based on its unique mechanism of action, Celinisol can be combined with multiple other drugs to improve efficacy
.
Image source: 123RF has good efficacy and controllable safety.
According to the data at the time of approval in the United States, the combination therapy of Celinisole and dexamethasone was used in the treatment of 83 patients with relapsed or refractory multiple myeloma Good results have been achieved: in these highly refractory patients, the combination therapy achieved a total remission rate of 25.
3%, and the remission duration was 3.
8 months
.
In China, in a phase 2 study called MARCH, a total of 83 patients with relapsed or refractory multiple myeloma received Celinisol combined with low-dose dexamethasone (Sd regimen, Celinisol every two weeks 80 mg, dexamethasone 20 mg every two weeks) treatment
.
These patients had received proteasome inhibitors, immunomodulators, and last-line treatment, but none of them had any effect
.
The median follow-up time was 9.
5 months
.
The research results show that the Sd scheme has good effectiveness and controllable safety
.
The patient’s objective response rate (ORR) was 26.
7%; the median duration of response (DOR) was 4.
6 months; and the median progression-free survival was 3.
7 months
.
Adverse events (TEAE) common treatment period occur include thrombocytopenia, nausea, leukopenia, anemia, lymphopenia psychosis
.
Image source: 123RF At present, several guidelines recommend Celiniso for the treatment of patients with relapsed and refractory multiple tumors, such as the National Comprehensive Cancer Network (NCCN) "NCCN Guidelines Insights Multiple Myeloma", Chinese Society of Clinical Oncology (CSCO) "2021 version of CSCO hematologic malignancies treatment guidelines" and so on
.
Celiniso was approved for marketing in China, providing a new oral treatment option for patients with multiple myeloma, which is expected to benefit more patients
.
Recommended reading China ushered in the first new crown neutralizing antibody combination therapy! The risk of hospitalization and death of patients is significantly reduced in urgent clinical needs! For the treatment of this disease, stuximab has been approved for marketing as a new treatment option, and PD-L1 inhibitors that can be injected subcutaneously have been approved for marketing! Some drug-resistant leukemias have new treatment options! The third-generation BCR-ABL inhibitor was approved in China The world's first approved anti-IL-5 monoclonal antibody came to China to treat eosinophilic granulomatous polyangiitis! References [1] Chinese Medical Doctor Association Hematology Physician Branch, et al.
, (2020).
Guidelines for the diagnosis and treatment of multiple myeloma in China (revised in 2020).
Chinese Journal of Internal Medicine, DOI:10.
3760/cma.
j.
cn112138-20200304- 00179.
[2] Information to be obtained for the drug approval documents of the China National Medical Products Administration on December 16.
Retrieved Dec 17, 2020, from https:// .
html [3] At the 2021 IMW annual meeting, Deqi Pharmaceutical announced the results of the Phase II clinical study of Celinisol in the treatment of relapsed and refractory multiple myeloma in China.
Retrieved Dec 17, 2021, from https:// .
cn/news/1334.
html Note: This article aims to introduce the progress of medical and health research and is not a recommendation for treatment
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
Combination of dexamethasone to treat relapsed or refractory multiple myeloma (RRMM) that has been previously treated and is refractory to at least one proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody
.
”
The approval of this drug in China is expected to bring new treatment options and hope for patients with relapsed or refractory multiple myeloma
.
Screenshot source: NMPA's official website.
Multiple myeloma (MM), the second-largest malignant tumor of the blood system, 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 approximately the blood system 10% of malignant tumors
.
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 the age of patients is showing a younger trend
.
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, and the number of deaths was 146,554
.
In recent years, with the development of proteasome inhibitors, immunomodulators, anti-CD38 monoclonal antibodies, CAR-T cell therapy, autologous hematopoietic stem cell transplantation and other therapeutic methods, as well as the application of combined treatment programs, the treatment of multiple myeloma It has been perfected and improved, and the patient's survival period has been significantly prolonged
.
However, 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 (that is, resistance to existing drugs)
.
For patients with relapse or drug resistance, the goal of treatment is to relieve the disease to the greatest extent, extend the progression-free survival period, and improve the quality of life
.
Image source: 123RF's first XPO1 inhibitor approved by the FDA According to public information, Celiniso is currently the first and only oral nuclear export protein 1 approved by the U.
S.
Food and Drug Administration (FDA) (XPO1) inhibitor is also the first drug that can be used to treat multiple myeloma and diffuse large B-cell lymphoma
.
In healthy people, oncogenes and tumor suppressor genes are in dynamic balance, while cancer patients have stronger expression of oncogenes and weaker expression of tumor suppressor genes
.
If the activity of oncogenes is inhibited, it is possible to inhibit the proliferation signal of tumor cells, and then cause tumor cells to undergo apoptosis
.
Nuclear export protein 1 (XPO1), also known as chromosomal region stabilizing protein 1, plays a vital role in maintaining cell homeostasis
.
The disorder of this protein plays a key role in the development of various solid tumors and hematological malignancies, and is highly expressed in tumor cells
.
Celiniso can promote the nuclear storage and activation of tumor suppressor protein and other growth regulatory proteins by inhibiting XPO1, and can reduce the level of a variety of oncogenic proteins in the cytoplasm, thereby arresting the tumor cell cycle and inducing tumor cell apoptosis , And normal cells are not affected
.
Based on its unique mechanism of action, Celinisol can be combined with multiple other drugs to improve efficacy
.
Image source: 123RF has good efficacy and controllable safety.
According to the data at the time of approval in the United States, the combination therapy of Celinisole and dexamethasone was used in the treatment of 83 patients with relapsed or refractory multiple myeloma Good results have been achieved: in these highly refractory patients, the combination therapy achieved a total remission rate of 25.
3%, and the remission duration was 3.
8 months
.
In China, in a phase 2 study called MARCH, a total of 83 patients with relapsed or refractory multiple myeloma received Celinisol combined with low-dose dexamethasone (Sd regimen, Celinisol every two weeks 80 mg, dexamethasone 20 mg every two weeks) treatment
.
These patients had received proteasome inhibitors, immunomodulators, and last-line treatment, but none of them had any effect
.
The median follow-up time was 9.
5 months
.
The research results show that the Sd scheme has good effectiveness and controllable safety
.
The patient’s objective response rate (ORR) was 26.
7%; the median duration of response (DOR) was 4.
6 months; and the median progression-free survival was 3.
7 months
.
Adverse events (TEAE) common treatment period occur include thrombocytopenia, nausea, leukopenia, anemia, lymphopenia psychosis
.
Image source: 123RF At present, several guidelines recommend Celiniso for the treatment of patients with relapsed and refractory multiple tumors, such as the National Comprehensive Cancer Network (NCCN) "NCCN Guidelines Insights Multiple Myeloma", Chinese Society of Clinical Oncology (CSCO) "2021 version of CSCO hematologic malignancies treatment guidelines" and so on
.
Celiniso was approved for marketing in China, providing a new oral treatment option for patients with multiple myeloma, which is expected to benefit more patients
.
Recommended reading China ushered in the first new crown neutralizing antibody combination therapy! The risk of hospitalization and death of patients is significantly reduced in urgent clinical needs! For the treatment of this disease, stuximab has been approved for marketing as a new treatment option, and PD-L1 inhibitors that can be injected subcutaneously have been approved for marketing! Some drug-resistant leukemias have new treatment options! The third-generation BCR-ABL inhibitor was approved in China The world's first approved anti-IL-5 monoclonal antibody came to China to treat eosinophilic granulomatous polyangiitis! References [1] Chinese Medical Doctor Association Hematology Physician Branch, et al.
, (2020).
Guidelines for the diagnosis and treatment of multiple myeloma in China (revised in 2020).
Chinese Journal of Internal Medicine, DOI:10.
3760/cma.
j.
cn112138-20200304- 00179.
[2] Information to be obtained for the drug approval documents of the China National Medical Products Administration on December 16.
Retrieved Dec 17, 2020, from https:// .
html [3] At the 2021 IMW annual meeting, Deqi Pharmaceutical announced the results of the Phase II clinical study of Celinisol in the treatment of relapsed and refractory multiple myeloma in China.
Retrieved Dec 17, 2021, from https:// .
cn/news/1334.
html Note: This article aims to introduce the progress of medical and health research and is not a recommendation for treatment
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
