FDA official announcement: approval opinion of zebutini in Baiji China! (full text translation attached)

FDA approved the treatment of relapsed refractory mantle cell lymphoma, the clinical trial results show that the effective rate of tumor reduction is very high For Immediate Release: November 14, 2019 Today, the U.S Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Today, the U.S Food and Drug Administration approved brukinsa (zanubrutinib) for the treatment of adult mantle cell lymphoma patients who have received at least one treatment “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow This is a life-threatening condition,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research “Clinical trials showed that 84% of patients saw tumor shrinkage with this therapy For patients whose disease relapses or becomes refractory, secondary therapies may be successful in providing another remission, And today's approval will provide patients with other treatment option Pazdur showed that: "mantle cell lymphoma usually responds well to the initial treatment, but eventually slows down or stops the effect, and cancer cells continue to grow, which is a life-threatening disease Clinical trials show that 84% of patients believe that this treatment will lead to tumor reduction For patients who relapse or become refractory, the second treatment may successfully provide another relief, and today's approval will provide another treatment option for patients " Mantle cell lymphoma is a type of non-Hodgkin’s lymphoma representing 3-10% of all non-Hodgkin’s lymphomas in the United States By the time it is diagnosed, mantle cell lymphoma has usually spread to the lymph nodes, bone marrow and other organs In relapsed lymphoma, the disease reappears or grows again after a period of remission, while in The disease does not respond to treatment or responses only briefly By the time of diagnosis, mantle cell lymphoma usually has spread to lymph nodes, bone marrow and other organs In recurrent lymphoma, the disease reappears or grows after a period of remission, while in refractory lymphoma, the disease has no or only transient response to treatment A single-arm clinical trial of Brukinsa included 86 patients with mantle cell lymphoma who had received at least one prior treatment The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate) In the trial, 84% of patients had tumor shrinkage with a median duration of response (time between the initial response to therapy and subsequent disease progression or relapse) of 19.5 months This trial was supported by an additional single-arm trial that included 32 patients, in which 84% of patients had tumor shrinkage with a median duration of response of 18.5 follow up clinical trial of months brukinsa included 86 patients with mantle cell lymphoma treated at least once The trial measured how many patients had a complete or partial tumor reduction (overall response rate) after treatment In the trial, 84% of patients had shrunk tumors, and the median response duration (the time between the initial response to treatment and subsequent disease progression or recurrence) was 19.5 months The trial was supported by another follow-up trial involving 32 patients, 84% of whom had a reduced tumor size and a median remission time of 18.5 months Common side effects for patients taking Brukinsa were decreased neutrophil count (white blood cells that fight against infection), decreased platelet count (a component of blood whose function is to react to bleeding from blood vessel injury by clumping, initiating a blood clot), upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin (oxygen-carrying protein in red blood cells), rash, bruising, diarrhea and cough During treatment, patients should be monitored for hemorrhage (bleeding), signs and symptoms of infection, cytopenias (decreased complete blood counts) and cardiac arrhythmias (irregular, rapid heart rate and abnormality in beating of the heart) Patients are advised to use sun protection if taking this therapy because there is a risk of other malignancies occurring including skin cancers The FDA advises health care professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Brukinsa Women who are pregnant or breastfeeding should not take Brukinsa because it may cause harm to a developing fetus or newborn baby The common side effects of patients taking brukinsa are neutrophil count (anti infective white blood cells), platelet count (a component of blood, whose function is to respond to bleeding caused by vascular injury and form thrombus), upper respiratory tract infection, decrease of white blood cell count, decrease of blood red protein (oxyprotein in red blood cells), rash, bruise, diarrhea and cough During the treatment, the patient's bleeding, infection symptoms and signs, cytopenia (pancytopenia) and arrhythmia (irregular, rapid and abnormal heart rate) should be monitored If a patient is receiving this treatment, sunscreen is recommended because of the potential for other cancers, including skin cancer The FDA recommends that health care professionals tell women of childbearing age and men with reproductive potential female partners to use effective contraception during treatment of brukinsa Pregnant or lactating women should not take brukinsa as it may cause harm to the developing fetus or newborn Brukinsa was granted Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients Further clinical trials may be required to verify and describe Brukinsa’s clinical benefit Brukinsa's accelerated approval has enabled the FDA to approve drugs in critical situations to meet unmet medical needs, and the results may reasonably predict the clinical benefits of patients Further clinical trials may be needed to validate and describe the clinical benefits of brukinsa The FDA granted this application Breakthrough Therapy designation, which expedites the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies Brukinsa also received Orphan Drug designation, Which provides includes to assist and enhance the development of drugs for rare diseases The FDA granted approval of brukinsa to beigene USA Inc FDA approved this breakthrough treatment plan and accelerated the development and review of drugs for severe diseases Initial clinical evidence shows that the drug may have substantial improvement over the existing treatment Brukinsa has also been assigned medication for rare diseases, which provides incentives to help and encourage the development of drugs to treat rare diseases FDA approved the production of brukinsa by Baiji China US branch The FDA, an agency within the U.S Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, FDA is an agency of the U.S Department of health and human services that protects public health by ensuring the safety, effectiveness and safety of human, veterinary, vaccines and other biological products, as well as medical devices The agency is also responsible for the safety and security of food supplies, cosmetics, dietary supplements, products that emit electronic radiation in the United States, and the regulation of tobacco products Editor in charge | Jenny tortoise statement: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.