Novartis filed a clinical trial application for CTL019 in China on Aug. 12, which has been accepted by the CDE. CTL019 is a breakthrough new CAR T-cell drug under Novartis, which is also the world’s first CAR T-cell therapy approved.
CTL019 Clinical Application Filed by Novartis in China | |||
Pharmaceutical product name | Acceptance No. | Registration class | Application type |
CTL019 | JXSL1900067 | Biological product for treatment | Import |
Source: Drug Clinical Trial Registration and Information Publicity Platform
The world’s first CAR T-cell therapy marketed
CAR T-cell therapies generally express the chimeric antigen receptors (CARs) on the surface of T cells and remove cancer cells using patients’ immune cells, being one of the most groundbreaking treatment means among oncology therapies at present.
Approved by the FDA for marketing on Aug. 30, 2017 with a trade name of Kymriah, Novartis’ CAR T-cell product: CTL019 is the first CAR T-cell therapy approved worldwide, which is used to treat relapsed/refractory acute lymphoblastic leukemia in children and young adults (2-25 years old) and priced at USD475,000.
Kymriah’s second indication was approved by the FDA on May 1, 2018 based on the previous Breakthrough Therapy Designation and corresponding clinical results, which is relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in adult patients.
Kymriah achieved global sales of USD76 million in 2018. Compared to the first generation, CTL019 therapy, the first therapy approved for marketing using the second-generation CAR T-cell technology, has additional intracellular costimulators which help strengthen the antitumor activity, with CAR T cells having stronger proliferation and persistence; it also has high stability and relatively mature process, being the mainstream technology at present.
According to the supportive clinical data, CTL019 showed extremely significant therapeutic effects in advanced patients with r/r blood tumor: its objective response rate and complete remission rate in pediatric patients with r/r acute lymphocytic leukemia (ALL) separately reached up to 95% and 83%.
Partial Clinical Trial Results of CTL019 | ||
Indication | r/r ALL in pediatric and young adult patients | DLBCL in adults |
Number of people | 63 | 68 |
Objective response rate (ORR) | 95% | 50% |
Complete remission rate | 83% | 32% |
Source: Organized according to public data
The competitor has striking performance and has taken the lead in the clinical trial in China
Kite Pharma’s KTE-C19 was approved by the FDA for marketing on Oct. 18, 2017, to become the world’s second CAR T-cell therapy approved for marketing, which is used to treat adult patients ...
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