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Singapore's first commercialized CAR-T therapy!

 Last Update: 2021-03-22
 Source: Internet
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News on March 11, 2021 /bioon.
com" target="_blank">/ - bioon.
com/tags/%E8%AF%BA%E5%8D%8E/">Novartis recently announced that under the new regulatory framework for cell, tissue and bioon.
com/genetherapy/" target="_blank">gene therapy products (CTGTP), the Singapore Health Sciences Authority (HSA) has approved Kymriah (tisagenlecleucel) as Singapore’s first commercial chimera Antigen receptor T cell (CAR-T) therapy.

bioon.
com" target="_blank">bioon.
com/tags/%E8%AF%BA%E5%8D%8E/">Novartis bioon.
com/genetherapy/" target="_blank">Gene Therapy

Kymriah is a CD19-directed genetically modified autologous T cell immune cell therapy.
It has been approved for the treatment of two deadly cancers.
The treatment options for these two cancers are limited and the prognosis has historically been poor.
Urgent need for therapy.

Unlike conventional small molecule or biological therapies, CAR-T cell therapy is a live T cell therapy product.
The principle of Kymriah is to genetically modify the patient’s T cells to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, which is an antigen protein expressed on the surface of a variety of blood tumor cells, including B cells Lymphoma and leukemia cells.

HSA approved Kymriah: (1) for the treatment of children and young adults with B-cell acute lymphoblastic bioon.
com/tags/%E7%99%BD%E8%A1%80%E7%97%85/">leukemia (ALL) who are refractory, relapsed after transplantation, or relapsed for the second or multiple times from 2 to 25 years old ; (2) It is used to treat adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after receiving two or more systemic therapies.

bioon.
com/tags/%E7%99%BD%E8%A1%80%E7%97%85/">leukemia

This approval is based on the review of two global registered CAR-T bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">clinical trials, JULIET and ELIANA.
In these trials, Kymriah demonstrated strong and durable response rates and consistent safety in two difficult-to-treat patient populations.

bioon.
com/course_video/lin-chuang-shi-yan-de-feng-xian-jian-kong239833.
html">Clinical Trials

Kymriah is a personalized treatment method that modifies the patient's own T cells to fight and kill cancer cells.
Bringing this new and innovative treatment to Singapore requires the cooperation of many health system stakeholders.
This includes obtaining regulatory approvals, validating and training qualified treatment centers for appropriate indications, and integrating delivery systems for personalized treatments that did not exist before to ensure the safe and seamless delivery of Kymriah to patients.

Singapore General Hospital (SGH) is the first Kymriah treatment center in Southeast Asia to be put into operation for the treatment of adult r/r DLBCL and young adult r/r B-cell ALL patients.
bioon.
com/tags/%E8%AF%BA%E5%8D%8E/">Novartis is currently discussing with the National University Hospital of Singapore (NUH) to expand the possibility of using Kymriah for adult r/r DLBCL and children and young adult r/r B-cell ALL patients.

bioon.
com/tags/%E8%AF%BA%E5%8D%8E/">Novartis

Professor William Hwang, Medical Director of the National Cancer Center of Singapore, said: “CAR-T therapy is a major advancement in immunotherapy strategies and an important advancement in individualized cancer treatment.
This therapy has shown great promise as a life-saving therapy.
Prospects, and bring new hope for blood cancer patients.
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Original source: Novartis receives approval for Kymriah (tisagenlecleucel) by Health Sciences Authority as Singapore's first commercially app roved CAR-T therapy

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