Sanofi's powerful mobilization agent, ShiBeiling, China approved

Highlights: autologous hematopoietic stem cell transplantation is an important means to reconstruct hematopoietic and immune function in patients with non-Hodgkin's lymphoma after radiotherapy and chemotherapy The State Drug Administration of China approved the combination of ShiBeiling (Prozac injection) and granulocyte colony stimulating factor, which is suitable for the mobilization of hematopoietic stem cells into peripheral blood in patients with non Hodgkin lymphoma, so as to facilitate the collection of hematopoietic stem cells and autotransplantation Research shows that the combination of ShiBeiling and granulocyte colony stimulating factor can make more patients have the opportunity to receive autotransplantation treatment and significantly prolong the disease-free survival period of patients December 11, 2018 / Meitong news agency / -- remember the blockbuster movie "go away!"! Tumor king, whose protagonist is a picture book writer suffering from non Hodgkin's lymphoma, died only 15 months after diagnosis In order to improve the cure hope of non-Hodgkin's lymphoma patients, Sanofi China announced today that the State Drug Administration has approved the use of ShiBeiling (Prozac injection) in combination with granulocyte colony-stimulating factor, which is suitable for mobilizing hematopoietic stem cells into peripheral blood in non-Hodgkin's lymphoma patients, so as to facilitate the completion of hematopoietic stem cell collection and autotransplantation As a new generation of hematopoietic stem cell transplantation mobilization agent, ShiBeiling can significantly improve the success rate of hematopoietic stem cell collection, so that patients can get more chances of cure through transplantation The prognosis of patients with high-risk non-Hodgkin's lymphoma is poor, which seriously affects the survival of patients with lymphoma is one of the most common hematological malignancies In China, the incidence rate of lymphoma is about 6.68/10, ranking tenth in the male high incidence of malignant tumors, and the mortality rate ranks tenth among all kinds of cancer in China Lymphoma is mainly classified into Hodgkin lymphoma and non Hodgkin lymphoma, of which the incidence rate of non - Hodgkin lymphoma accounts for about 90% of all lymphoma The initial symptoms of the disease are very insidious, described as "the most camouflaged cancer." The traditional treatment of non-Hodgkin's lymphoma is mainly chemotherapy, which can kill a large number of tumor cells 50% - 60% of patients can get long-term survival through radiotherapy, chemotherapy and biotherapy, but the prognosis of relapsed and refractory invasive patients is poor, which is still a major challenge for clinicians Autologous hematopoietic stem cell transplantation is a hope for the cure of high-risk non Hodgkin's lymphoma patients "For some high-risk patients, we can choose autologous hematopoietic stem cell transplantation to improve the possibility of disease relief or cure and reduce the probability of recurrence." Professor Huang Xiaojun, director of the Institute of Hematology, Peking University People's Hospital, said, "at present, in clinical practice, autologous peripheral blood stem cell transplantation has become one of the important means to treat blood system diseases, and has significant advantages in improving the quality of life of patients and reducing the burden of diseases." Effective mobilization of peripheral blood stem cell autotransplantation process is an important link in the success of hematopoietic stem cell autotransplantation Because the content of hematopoietic stem cells in peripheral blood (except bone marrow) is very low, it is necessary to "mobilize" hematopoietic stem cells to release from bone marrow to peripheral blood, and then obtain enough autologous hematopoietic stem cells to meet the clinical application through blood cell separation and collection technology If you think of the marrow as a factory that produces hematopoietic stem cells, without the mobilization plan, the production of the factory is only at the normal level, only a small number of hematopoietic stem cells can be dissociated to the peripheral blood; and after the use of the mobilization agent, the hematopoietic stem cells in the marrow can be accelerated to produce and overflow to the peripheral blood, so there is a chance to collect enough hematopoietic stem cells Prior to the marketing, patients could only use traditional mobilization strategies such as granulocyte colony stimulating factor to help mobilize hematopoietic stem cells into peripheral blood Data shows that the failure rate of traditional mobilization strategy is high, which leads to many patients unable to transplant, delays treatment and increases the follow-up cost and resource utilization Professor Huang Xiaojun stressed: "the mobilization of peripheral blood stem cells is an important link in stem cell transplantation, which directly determines whether the patients can carry out transplantation Therefore, the most important thing is to identify patients with poor mobilization before collection, intervene as early as possible and prevent mobilization failure effectively " ShiBeiling can significantly promote the mobilization success rate of autologous hematopoietic stem cells (CD34 + cells), which is one of the characteristics of hematopoietic stem cells Many international guidelines recommend that the best amount of stem cell collection should be > = 5 million / kgcd34 + cells / kg ShiBeiling is a kind of hematopoietic stem cell mobilization agent, which can mobilize the hematopoietic stem cells of bone marrow to enter the blood stream and increase the number of stem cells in the blood circulation Even for patients with very low number of circulating CD34 + cells, it still has important benefits Two global phase III clinical studies have fully proved the effectiveness and safety of the combination of ShiBeiling and granulocyte colony stimulating factor The mobilization effect of the combination of ShiBeiling and granulocyte colony stimulating factor is better than that of the single use of granulocyte colony stimulating factor Compared with placebo, ShiBeiling does not increase the incidence of adverse events In a study of 298 patients with non-Hodgkin's lymphoma, 59% of patients mobilized by ribeline and granulocyte colony-stimulating factor collected > = 5 million / kg CD34 + cells from peripheral blood in four or fewer collection periods, and 20% of patients mobilized by placebo and granulocyte colony-stimulating factor In Chinese clinical research data, it also shows that this innovative treatment scheme can bring more clinical benefits to patients In a phase III study to evaluate the efficacy of the product in 100 Chinese patients with non Hodgkin's lymphoma, 62% of the patients who received mobilization of ribeline and granulocyte colony-stimulating factor collected more than or equal to 5 million / kg CD34 + cells from peripheral blood in 4 or less stem cell collections, while only 20% of the patients who received mobilization of placebo and granulocyte colony-stimulating factor achieved this result "For patients who are suitable for autotransplantation, effective mobilization of stem cells and successful transplantation can significantly prolong disease progression free survival, improve prognosis and quality of life Combined with mobilization of granulocyte colony-stimulating factor, more patients can collect enough hematopoietic stem cells to carry out autotransplantation with the best number of hematopoietic stem cells, accelerate the recovery time of hematopoietic system, reduce blood transfusion demand, infection rate and hospitalization time At the same time, the combined scheme can reduce the number of times of blood cell separation, thus reducing the acquisition time and resource occupation " Professor Huang Xiaojun said, "for patients who have the risk of poor mobilization, we should combine the use of ShiBeiling for preemptive intervention to prevent mobilization failure; for patients who fail in the initial mobilization plan, we recommend the combination of ShiBeiling for rescue treatment." "As a global pioneer in the field of cancer treatment, Sanofi's tumor drugs cover breast cancer, lung cancer, colorectal cancer, liver cancer, lymphoma and other fields, and actively save the lives of adults and children with solid tumors and blood tumors," said Wu Qingyi, vice president of Sanofi China and head of special medicine business department The approval of Shi Beiling in China is encouraging news for non Hodgkin's lymphoma patients Especially for patients who fail to use the traditional mobilization scheme, the successful mobilization again is their hope to alleviate the disease progress In the future, we will continue to uphold our commitment to Chinese patients, continue to introduce high-quality innovative drugs, actively explore and promote the accessibility and affordability of innovative drugs, so as to benefit more Chinese patients " NHL is a group of heterogeneous lymphoproliferative diseases, which originated from B lymphocyte, T lymphocyte or NK cell NHL lesions mainly occur in lymph nodes, spleen, thymus and other lymphoid organs, but also in lymphoid tissues and organs outside the lymph nodes of the LYMPHOPOIETIC system of malignant tumors NHL is complex in pathological classification, clinical manifestation and treatment individualization Different types have different prognosis Here are several main types of NHL: 1 Diffuse large B-cell lymphoma (DLBCL): the most common type of NHL, accounting for 30% - 40% of adult NHL in the West and 35% - 50% in China The median age of onset was 50-70 years, slightly higher in males than in females 2 follicular lymphoma (FL): the most common inert lymphoma in Europe and America, accounting for about NHL incidence rate of 20%~30%, including China, including low incidence rate in Asia, and incidence of less than 10% of NHL The median age of onset was about 60 years old 3 Chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL): it belongs to inert B-cell lymphoma CLL and SLL are different manifestations of the same disease SLL usually has no leukaemia like manifestations, while CLL is mainly affected by bone marrow and peripheral blood CLL/SLL accounts for about 7% to 10% of NHL in Europe and America It is the most common type of leukemia in western countries, while in Asia and China, it has a low incidence rate, accounting for about 1%~3% of NHL The median age of onset was 65 years old, and the ratio of male to female was 1.5-2:1 4 Mantle cell lymphoma (MCL): about 5% ~ 10% of NHL, the ratio of male to female is 2:1 ~ 3:1, the median age of onset is about 65 years old The natural course can be aggressive and inert The response to treatment is similar to inert lymphoma, which is an incurable disease at present The survival time of MDC is about 3-5 years 5 Peripheral T-cell lymphoma (PTCL): it is a group of lymphoid system malignant tumors originated from thymus post mature T-lymphocytes Peripheral T-cell lymphoma non-specific type (ptcl-nos) is the most common type of PTCL In western countries, PTCL-NOS accounts for 7%~10% of all NHL, and the incidence rate in Asian countries is significantly higher than that in Europe and America, accounting for NHL of all 15%~22% About hematopoietic stem cell transplantation, hematopoietic stem cell transplantation is a treatment method to reconstruct the normal hematopoietic and immune function of patients The patients were pretreated by whole body irradiation, chemotherapy and immunotransplantation, then the allogeneic donors or patients' own hematopoietic stem cells were infused through peripheral blood vessels, and the hematopoietic stem cells were homing to the patients' bone marrow, further self-renewal, proliferation and differentiation, and finally all kinds of mature blood cells were obtained According to the source of hematopoietic stem cells, it can be divided into bone marrow, peripheral blood, cord blood, etc According to the relationship between donors and recipients, they are divided into: autotransplantation of hematopoietic stem cells, homogeneic transplantation of hematopoietic stem cells and allogeneic transplantation of hematopoietic stem cells Among them, autologous stem cell transplantation refers to the cryopreservation of the patient's own hematopoietic stem cells (bone marrow or peripheral blood) after collection, and then transfusion to the patient to reconstruct hematopoiesis after a large dose of radiotherapy and chemotherapy Compared with allogeneic hematopoietic stem cell transplantation, because there is no need for donor, graft-versus-host disease will not occur, transplantation-related complications are mild, and the risk of transplantation is low Peripheral blood stem cell transplantation does not need to collect bone marrow through anesthesia It has the characteristics of rapid implantation, rapid recovery of granulocytes and platelets, and less supportive treatment Large sample meta-analysis showed that peripheral blood stem cell transplantation had advantages in reducing the recurrence rate and improving the disease-free survival rate, and was more suitable for the patients who were in the stage of disease progression or had the tendency of recurrence before transplantation About the general name of ShiBeiling: Prozac injection trade name: ShiBeiling mozobil English Name: plerixaforinjection [indication] this product is used in combination with granulocyte colony stimulating factor (G-CSF), which is suitable for mobilizing hematopoietic stem cells (HSC) into peripheral blood in patients with non Hodgkin lymphoma (NHL), so as to complete HSC collection and autotransplantation [Specification] 1.2ml: 24mg [dosage] patients received G-CSF once a day, a total of 4 days after the start of the drug treatment 11 before each acquisition