Novartis’ Kymriah Becomes Singapore’s First Commercially Approved CAR-T Therapy for Two B-Cell Malignancies
Mar 11, 2021 19:39
CST Updated
19:39
Novartis
Drug Development and Manufacturing
HSA
The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Singapore Government, formed by integrating five specialized agencies: the Centre for Drug Evaluation, the Institute of Science and Forensic Medicine, the National Pharmaceutical Administration, the Product Regulation Department, and the Singapore Blood Transfusion Service. The agency’s vision is to become a leading authority in safeguarding and promoting national health and safety.
March 11, 2021 News /Bio ValleyBIOON/ --Novartis(Novartis) recently announced that, based on new cell, tissue, andGene TherapyUnder the product (CTGTP) regulatory framework, the Health Sciences Authority (HSA) of Singapore has approved Kymriah (tisagenlecleucel) as the first commercialized chimeric antigen receptor T-cell (CAR-T) therapy in Singapore.
Kymriah is a CD19-directed genetically modified autologous T-cell immunotherapy approved for the treatment of two fatal cancers with limited therapeutic options and historically poor prognoses, addressing the urgent need for new therapies in these patients.
Unlike conventional small-molecule drugs or biologics, CAR-T cell therapy is a living T-cell therapeutic product. Kymriah works by genetically modifying the patient’s T cells to express a chimeric antigen receptor (CAR) designed to target CD19, an antigenic protein expressed on the surface of various hematologic tumor cells, including those in B-cell lymphomas and leukemias.
HSA approves Kymriah: (1) for the treatment of B-cell acute lymphoblastic leukemia in patients aged 2 to 25 years with refractory, post-transplant relapsed, or second or subsequent relapsed diseaseLeukemia(ALL) pediatric and young adult patients; (2) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who have received two or more prior systemic therapies.
This approval is based on two global registration CAR-TClinical TrialsReview of JULIET and ELIANA. In these trials, Kymriah demonstrated robust and durable response rates and a consistent safety profile in two difficult-to-treat patient populations.
Kymriah is a personalized therapy that modifies patients’ own T cells to combat and kill cancer cells. Bringing this innovative new treatment to Singapore requires collaboration among numerous healthcare system stakeholders. This includes obtaining regulatory approval, validating appropriate indications and providing training at qualified treatment centers, and integrating delivery systems for personalized therapies that did not previously exist, to ensure the safe and seamless delivery of Kymriah to patients.
Singapore General Hospital (SGH) is the first Kymriah treatment center to become operational in Southeast Asia, providing therapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).NovartisDiscussions are currently underway with the National University Hospital (NUH) in Singapore to expand access to Kymriah for adult patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) and pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
Professor William Hwang, Medical Director of the National Cancer Centre Singapore, stated, “CAR-T therapy represents a significant advancement in immunotherapy strategies and an important step forward in personalized cancer treatment. This therapy has shown great promise as a life-saving treatment, bringing new hope to patients with blood cancers.”(Bioon.com)
Original Source: Novartis receives approval for Kymriah (tisagenlecleucel) by Health Sciences Authority as Singapore's first commerciallyapproved CAR-T therapy