Novartis announced that the Health Sciences Authority (HSA) has approved Kymriah (tisagenlecleucel) as the first commercial chimeric antigen receptor T-cell (CAR-T) 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 that have limited treatment options and historically poor outcomes, addressing the critical need for new therapies for these patients.
HSA approved Kymriah for the treatment of pediatric and young adult patients from 2 to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy[1].
The approval 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[1],[2],[3].
Kymriah is an individualised treatment that modifies a patient's own T-cells to fight and kill cancer cells. Bringing this new innovative therapy to Singapore requires collaboration among many health system stakeholders. This includes obtaining regulatory approval, the validation and training of qualified treatment centres for the appropriate indications, and integrating a delivery system that did not previously exist for individualised treatments to ensure safe and seamless delivery of Kymriah to patients.
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.
Professor William Hwang, Medical Director of the National Cancer Centre Singapore, Head of SingHealth Duke-NUS Cell Therapy Centre, Senior Consultant of SingHealth Duke-NUS Blood Cancer Centre, and Senior Consultant for Haematology at SGH said, "CAR-T therapy is a major advancement in the emergence of immune-based strategies and is a significant step forward in individualised cancer treatment. This therapy shows great promise as a life-saving treatment and offers new hope to patients with blood cancers and disorders."
"80-85% of acute lymphoblastic leukemia patients are cured with frontline chemotherapy. However, for 15% of patients, when front-line therapies have failed, the new therapies are needed. This regulatory approval for the wider availability of treatment options including CAR-T therapy is welcome." said Professor Allen Yeoh, Head and Senior Consultant of the Division of Paediatric Haematology and Oncology of the Khoo Teck Puat-National University Children's Medical Institute, NUH and National University Cancer Institute, Singapore (NCIS).
Meeting unmet patient needs
ALL is a type of cancer that affects the blood and bone marrow[5]. ALL is the most common type of childhood leukemia[4], and for at clinically high risk patients who relapse from standard of care therapies, the outlook is poor[6]. These poor outcomes occur in more than half of the cases of relapsed ALL patients, in spite of patients having to undergo multiple treatments, including chemotherapy, radiation, targeted therapy, or stem cell transplant, and further highlights the need for new treatment options6.
DLBCL is an aggressive, complex and difficult to treat form of non-Hodgkin lymphoma, accounting for up to 40% of all cases globally[7]. For patients who relapse or do not respond to existing treatment options, there are limited treatment options that provide durable responses, and survival rates are low for the majority of patients due to ineligibility for autologous stem cell transplant (ASCT) or unresponsiveness to salvage chemotherapy.[8]
Pionee...
(All Rights Reserved)