FDA today accelerates approval of the first specific leukemia therapy, which is expected to completely eliminate the root cause

FDA today accelerates approval of the first specific leukemia therapy, which is expected to completely eliminate the root cause

March 30, 2018 Source: WuXi PharmaTech (Wei Signal WuXiAppTecChina)

Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];

Today, the US FDA announced an accelerated approval of Blincyto (blinatumomab) for expanded indications, allowing this new drug from Amgen to treat B-cell precursor acute lymphoblastic leukemia (ALL) and still have remission during remission. Small residual lesions (MRD) in children and adults. It is worth mentioning that this is the first treatment approved by the US FDA for the treatment of MRD-positive ALL.

B cell precursor ALL is a cancer that develops rapidly in the bone marrow and progresses rapidly. Excessive immature white blood cells are produced in the patient's bone marrow, affecting the function of the bone marrow. After these patients have been treated, there will still be many people with tiny residual lesions in their bodies. Although these lesions could not be found under microscopic examination, they left a hidden danger of recurrence of the disease.

Blincyto, approved today, is an innovative drug that binds CD19 on the surface of leukemia cells to CD3 on the surface of immune cells, squashing immune cells near leukemia cells, allowing them to better perform the latter. attack. The new drug was first approved in 2014 and is currently available for the treatment of Philadelphia-negative relapsed or refractory B-cell ALL, or Philadelphia chromosome-positive ALL.

In a one-arm clinical study, Blincyto showed good results in patients with MRD-positive ALL. These patients had one or two complete remissions, but there were still cancer cells in the bone marrow, accounting for about one-thousandth of the total number of cells. After treatment, even if high-precision detection of one cell can be picked from 10,000 cells, MRD cannot be detected in the patient, confirming the effect of Blincyto. Overall, 70% of patients could no longer detect MRD, and more than half had survived 22.3 months in the disease. Based on the potential of this new drug, the US FDA has granted eligibility and priority review qualifications for orphan drugs. Under good clinical results, the US FDA has decided to accelerate the approval of the new drug market today, so that it will benefit patients as soon as possible.

“This is the first FDA-approved treatment for MRD-positive ALL,” said Dr. Richard Pazdur, Director of the Center for Excellence in Oncology and Executive Director of the Office of Hematology and Oncology Products at the FDA. “Patients with MRD are more likely to have recurrence. Therefore, a therapy that eliminates very low levels of residual leukemia cells is expected to help prolong the remission of cancer. We look forward to learning more about how Blincyto can reduce MRD. In more experiments, we are evaluating how Blincyto affects MRD positivity. The long-term survival of the patient."

According to the plan, Blincyto, which has been approved for accelerated, still needs randomized controlled trials to verify that a reduction in MRD can lead to an improvement in survival or progression-free survival. We expect that the next trial will be equally successful, and patients will be able to welcome more ways to control the disease.

Reference material

[1] FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

[2] Anjin official website

Vitamins

Vitamins are a type of trace organic substances that humans and animals must obtain from food in order to maintain normal physiological functions. They play an important role in human growth, metabolism and development. Vitamins do not participate in the formation of human cells in the body, nor do they provide energy for the human body. Vitamins are a class of organic compounds necessary for maintaining good health.

Our company provides group A vitamins, group B vitamins, B12, etc.

Vitamin Tablet,Food Grade Vitamin,Vitamins For Energy,Water Soluble Vitamins

XI AN RHINE BIOLOGICAL TECHNOLOGY CO.,LTD , https://www.rhinebioteches.com