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Kymriah - The First Commercial CAR-T Cell Therapy Approved in Singapore Details

CAR-T cell therapy is a complex and extremely costly cancer treatment across the globe. On dated 9th March 2021, Novartis announced that the Health Sciences Authority (HSA) has approved Kymriah (tisagenlecleucel) CAR-T cell therapy in Singapore under the new cell, tissue and gene therapy products (CTGTP) regulatory framework. Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two life-threatening cancers B-cell acute lymphoblastic leukemia (ALL) and relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) that have limited treatment options and historically poor outcomes, addressing the critical need for new therapies for these patients.

The approval of Kymriah in Singapore was based on the review of two global registration CAR-T clinical trials, JULIET and ELIANA. In these trials, Kymriah demonstrated strong and durable response rates and a consistent safety profile in two difficult-to-treat patient populations.

Singapore General Hospital (SGH) is the first Kymriah treatment centre to become operational in Southeast Asia to treat adult r/r DLBCL and young adult r/r B-cell ALL patients. Novartis is currently in discussions with the National University Hospital (NUH) to expand the availability of Kymriah for both adult r/r DLBCL and pediatric and young adult r/r B-cell ALL patients. The approval of Kymriah in Singapore and the presence of these regional centers of excellence will enable the city state to help an underserved patient population in the Southeast Asia region where treatment unmet needs are present.

According to the MNG Tracker research titled “Global CAR-T Cell Therapy Market by Application (Acute Lymphoblastic Leukaemia (ALL), Diffuse Large B Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM)), by Regions (North America, Europe, Asia Pacific, Latin America Middle East, Africa), by Antigens (CD19, CD20, GD2, CD22, CD30, CD33, HER2, MESO, EGFRvIII, Others) Market Products (Yescarta, Kymriah)”, global CAR-T Cell therapy market is anticipated to grow over 20 percent CAGR during the forecasting period and likely to touch nearly US$ 8 Billion landmarks in 2028. Asia Pacific market is expected to grow with the highest CAGR during the forecasting period.

Global CAR-T Cell Therapy Market/ Kymriah Approval