Drugs / Tisagenlecleucel
Tisagenlecleucel
also known as
CART19 · CTL019 · allo-CART-19 · CAR-T19/CAR-T22 · CART-19 and 20 cells · CART-19/22 · huCART-19 · KYMRIAH · +1 more
Cell therapy targets CD19 via depletion
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-cell acute lymphoblastic leukemia 1 milestone | |||||
| Filed | US (FDA) | — | B-cell acute lymphoblastic leukemia | — | “Earlier this year, Novartis submitted a BLA for CTL019 to the FDA” novartis.com ↗ |
| Filed diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | Kymriah | diffuse large B-cell lymphoma | — | “Kymriah (tisagenlecleucel, formerly CTL019) filed with FDA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma” novartis.com ↗ |
| Filed follicular lymphoma, susceptibility to 2 milestones | |||||
| Filed | US (FDA) | Kymriah | follicular lymphoma, susceptibility to | 2022-02-02 | “Kymriah FDA and EMA accepted a Supplemental Biologics License Application and Type II Variation, respectively, in adult patients with relapsed or refractory follicular lymphoma” novartis.com ↗ |
| Filed | EU (EMA) | Kymriah | follicular lymphoma, susceptibility to | 2022-02-02 | “Kymriah FDA and EMA accepted a Supplemental Biologics License Application and Type II Variation, respectively, in adult patients with relapsed or refractory follicular lymphoma” novartis.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Kymriah | — | 2018-08-23 | europa.eu ↗ |
Trials 51
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2022-11-03 | NeoImmuneTech | Results NeoImmuneTech to Present First Data on NT-I7 (efineptakin alfa) in Combination with CAR-T tisagenlecleucel, at 2022 ASH Annual Meeting neoimmunetech.com ↗
Early preliminary results show NT-I7 treatment led to a sustained increase in absolute lymphocyte counts (ALC) and increased CAR-T cell absolute numbers in the peripheral blood |
| 2022-06-12 | Novartis Pharmaceuticals | Results Novartis five-year Kymriah® data show durable remission and long-term survival maintained in children and young adults with advanced B-cell ALL novartis.com ↗
For the 79 patients treated with Kymriah in this study, the five-year overall survival (OS) rate was 55% (95% CI, 43-66), while the median event-free survival (EFS) for patients in remission within three months of infusion (n=65) was 43.8 months. |
| 2022-05-28 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma novartis.com ↗
Basel, May 28, 2022 — Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2022-05-04 | Novartis Pharmaceuticals | Regulatory Novartis Kymriah® receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma novartis.com ↗
Novartis announced today that the European Commission (EC) has approved Kymriah ® (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2022-03-25 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe novartis.com ↗
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the European Commission to approve Kymriah ® (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2021-12-11 | Novartis Pharmaceuticals | Results Novartis Kymriah® demonstrates strong responses in high-risk patients with relapsed or refractory follicular lymphoma in extended study follow-up novartis.com ↗
In the subgroup analysis, results showed high rates of durable responses were induced by Kymriah in patients for the majority of high-risk disease subgroups, who typically have a poor prognosis. |
| 2021-10-27 | Novartis Pharmaceuticals | Regulatory Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma novartis.com ↗
The FDA has also granted priority review to the company’s sBLA for Kymriah in adult patients with r/r FL. |
| 2021-08-24 | Novartis Pharmaceuticals | Results Novartis provides update on BELINDA study investigating Kymriah® as second-line treatment in aggressive B-cell non-Hodgkin lymphoma novartis.com ↗
The BELINDA study did not meet its primary endpoint of event-free survival compared to treatment with the standard-of-care (SOC). |
| 2021-06-02 | Novartis Pharmaceuticals | Results Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma novartis.com ↗
Novartis today announced robust data from the primary analysis of the pivotal Phase II ELARA trial of Kymriah ® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL) 1 . |
| 2020-12-05 | Novartis Pharmaceuticals | Results Novartis analyses confirm benefit of Kymriah® with clinically meaningful rates of complete response seen in patients with certain advanced lymphomas novartis.com ↗
Interim analysis from the investigational ELARA study shows, 65% of patients with r/r follicular lymphoma evaluated for efficacy achieved a complete response and the overall response rate was 83% |
| 2020-10-30 | Novartis Pharmaceuticals | Regulatory Novartis expands Kymriah® manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia novartis.com ↗
Novartis today announced the receipt of marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe ("FBRI") to manufacture and supply commercial Kymriah ® (tisagenlecleucel) for patients in Japan. |
| 2020-08-23 | NeoImmuneTech | Regulatory NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1b Study of NT-I7 (efineptakin alfa) and Kymriah® (tisagenlecleucel) in Relapsed/Refractory Large B-Cell Lymphoma neoimmunetech.com ↗ |
| 2020-08-04 | Novartis Pharmaceuticals | Results Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma novartis.com ↗
At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee. |
| 2020-04-22 | Novartis Pharmaceuticals | Regulatory Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma novartis.com ↗
Novartis today announced that the US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah ® (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL). |
| 2019-12-09 | Novartis Pharmaceuticals | Results Novartis Kymriah® demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting novartis.com ↗
Novartis today announced results from two analyses of real-world experience with Kymriah ® (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications. |
| 2018-12-01 | Novartis Pharmaceuticals | Results Novartis announces longer-term analyses from pivotal Kymriah® trials that showed durable responses are maintained in patients with advanced blood cancers novartis.com ↗
In the updated analysis from ELIANA, Kymriah demonstrated an 82% remission rate within 3 months in pediatric patients with r/r ALL; relapse-free survival was 62% at 24 months, with median duration of remission still not reached[1] |
| 2018-08-27 | Novartis Pharmaceuticals | Regulatory Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel) novartis.com ↗
Novartis today announced that the European Commission (EC) has approved Kymriah ® (tisagenlecleucel, formerly CTL019). |
| 2018-08-27 | The Medicines Company | Regulatory Novartis erhält die Zulassung für seine CAR-T-Zell-Therapie Kymriah® (Tisagenlecleucel) von der Europäischen Kommission novartis.com ↗
Novartis hat heute die Marktzulassung von Kymriah® (Tisagenlecleucel, ehemals CTL019) durch die Europäische Kommission (EK) angekündigt. |
| 2018-06-29 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Kymriah® for treating two aggressive blood cancers, marking important medical advance for patients in Europe novartis.com ↗ |
| 2018-06-29 | The Medicines Company | Regulatory Novartis erhält positive CHMP-Stellungnahme für Kymriah® zur Behandlung zweier aggressiver Blutkrebsarten - ein wichtiger medizinischer Fortschritt für Patientinnen und Patienten in Europa novartis.com ↗
Die Empfehlung bringt Novartis der Möglichkeit näher, Kymriah in der EU betroffenen Patienten zur Verfügung zu stellen, die dringend neue Behandlungsoptionen benötigen |
| 2018-06-16 | Novartis Pharmaceuticals | Results Novartis JULIET trial of Kymriah demonstrates more than one-year durability of responses in adults with relapsed or refractory DLBCL novartis.com ↗
Novartis today announced 14-month results from the pivotal JULIET clinical trial showing ongoing durable responses are achievable with Kymriah ® (tisagenlecleucel) when administered to adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). |
| 2018-05-07 | Lunan Better Pharmaceutical Co., LTD. | Regulatory 新时代药业PD-1单抗临床申请获得承办 lunan.com.cn ↗
美国FDA批准了诺华的CAR-T细胞治疗药物Kymriah(tisagenlecleucel，CTL019)，用于治疗复发或难治性大B细胞淋巴瘤的成人患者(先前接受过两次或以上的系统治疗)，其中包括最常见的非霍奇金淋巴瘤形式—弥漫性大B细胞淋巴瘤(DLBCL)以及起因于滤泡性淋巴瘤(FL)的高级别B细胞淋巴瘤和DLBCL。 |
| 2018-05-01 | Novartis Pharmaceuticals | Regulatory Kymriah® (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma novartis.com ↗
Kymriah is now the only CAR-T cell therapy to receive FDA approval for two distinct indications in non-Hodgkin lymphoma (NHL) and B-cell ALL. |
| 2018-01-31 | Novartis Pharmaceuticals | Results Novartis announces NEJM publication of updated analysis from ELIANA trial showing longer-term durable remissions with Kymriah(TM) in children, young adults with r/r ALL novartis.com ↗
In the analysis of 75 infused patients with three or more months of follow-up, Kymriah demonstrated an overall remission rate of 81% (95% CI: 71% - 89%). |
| 2018-01-17 | Novartis Pharmaceuticals | Regulatory Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL novartis.com ↗
Filing acceptance marks second Priority Review granted to Kymriah by the FDA for two distinct indications, underscoring the potential of first ever FDA-approved CAR-T therapy |
| 2017-12-10 | Novartis Pharmaceuticals | Results Primary analysis results from Novartis pivotal JULIET trial show Kymriah(TM) (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer novartis.com ↗
Novartis today announced updated results from the JULIET clinical trial demonstrating sustained responses with Kymriah TM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). |
| 2017-11-06 | Novartis Pharmaceuticals | Regulatory Novartis reaches another regulatory milestone for CTL019 (tisagenlecleucel) with submission of its MAA* to EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL novartis.com ↗
Novartis today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications. |
| 2017-11-01 | Novartis Pharmaceuticals | Results Novartis presents data at ASH for patients with serious blood disorders like lymphoma, leukemia and sickle cell disease novartis.com ↗
Primary results of pivotal Kymriah TM Phase II JULIET study in relapsed/refractory DLBCL |
| 2017-10-31 | Novartis Pharmaceuticals | Regulatory Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy novartis.com ↗
Novartis today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah TM |
| 2017-08-30 | Novartis Pharmaceuticals | Regulatory Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice novartis.com ↗
Kymriah is the first therapy based on gene transfer approved by the FDA. |
| 2017-07-12 | Novartis Pharmaceuticals | Regulatory Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL novartis.com ↗
The panel's unanimous recommendation in favor of CTL019 moves us closer to potentially delivering the first-ever commercially approved CAR-T cell therapy to patients in need, |
| 2017-06-23 | Novartis Pharmaceuticals | Results Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL novartis.com ↗
Novartis today announced updated results from the ELIANA clinical trial demonstrating CTL019 (tisagenlecleucel) remission rates are maintained at six months in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). |
| 2017-06-07 | Novartis Pharmaceuticals | Results Novartis interim results from global, pivotal CTL019 trial show durable complete responses in adults with r/r DLBCL novartis.com ↗
The global, pivotal study showed a three-month overall response rate (ORR) of 45% (23 of the 51 patients evaluated), with 37% achieving a complete response (CR) and 8% achieving a partial response (PR), respectively. |
| 2017-04-18 | Novartis Pharmaceuticals | Regulatory Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough Therapy designation for treatment of adult patients with r/r DLBCL novartis.com ↗ |
| 2017-04-18 | Carina Biotech Limited | Regulatory Novartis Receives FDA Breakthrough carinabiotech.com ↗
Novartis CAR-T cell therapy CTL019 receives FDA breakthrough therapy designation for treatment of adult patients with r/r DLBCL |
| 2017-03-29 | Novartis Pharmaceuticals | Regulatory Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review novartis.com ↗
Basel, March 29, 2017 - Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). |
| 2016-12-04 | Novartis Pharmaceuticals | Results Novartis presents results from first global registration trial of CTL019 in pediatric and young adult patients with r/r B-ALL novartis.com ↗
The global Phase II study found that 82% (41 of 50) of infused patients achieved complete remission or complete remission with incomplete blood count recovery at three months post CTL019 infusion. |
| 2015-12-07 | Novartis Pharmaceuticals | Results Novartis highlights new CTL019 Phase II data demonstrating 93% complete remission in pediatric patients with r/r ALL novartis.com ↗
The study found that 55 of 59 patients (93%) experienced complete remissions (CR) with CTL019. |
| 2015-12-06 | Novartis Pharmaceuticals | Results Novartis announces new CTL019 study data demonstrating overall response in adult patients with certain types of lymphoma novartis.com ↗ |
| 2015-11-30 | Novartis Pharmaceuticals | Results Novartis highlights clinical advances at ASH 2015, underscoring leadership in hematology research novartis.com ↗
Sustained Remissions Following Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed or Refractory CD19+ Lymphomas |
| 2015-06-01 | Novartis Pharmaceuticals | Results Novartis highlights CTL019 data showing its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma novartis.com ↗
Thirteen of 19 evaluable patients responded to the therapy. |
All press releases naming this drug 42 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tisagenlecleucel | “We evaluated long-term outcomes in 38 patients with relapsed or refractory B-cell non-Hodgkin lymphomas (24 patients with large B-cell lymphoma and 14 with follicular lymphoma)...” PMID 42341302 ↗ Jun 202626“This trial evaluates the CMR rate 12 weeks after tisagenlecleucel (CTL019) infusion, the incidence and severity of adverse events, progression-free survival, and overall...” NCT04161118 ↗ “Tisagenlecleucel, an anti-CD19 chimeric antigen receptor T cell therapy, has demonstrated efficacy in children and young adults with relapsed/refractory B cell acute...” PMID 34353848 ↗ Aug 2021 “The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel (CTL019) has an 81% response rate in children with relapsed or chemotherapy refractory (r/r) B-cell...” PMID 31815579 ↗ Dec 2019 “A phase II trial of TisaGenlecleucel (CTL019) in Elderly Patients with First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma” NCT04161118 ↗ “Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).” NCT02435849 ↗ |
| Known as | allo-CART-19 | “At dosing, patients will receive redirected donor lymphocytes targeted against CD19 (allo-CART-19 cells).” NCT01551043 ↗ |
| Known as | CAR-T19/CAR-T22 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04204161 ↗ |
| Known as | CART-19 and 20 cells | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06160362 ↗ |
| Known as | CART-19/22 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03614858 ↗ |
| Known as | CART19 | “The target dose range administered in this study is 1-5x108 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x107 CART19), 30% on Day 1 (3x107-1.5x108 CART19), 60%...” NCT02640209 ↗24“CD19-targeted chimeric antigen receptor-T cell (CART19) therapy is clinically effective in patients with relapsed or refractory B-cell lymphoma (BCL)” PMID 41123227 ↗ Oct 2025 “A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.” NCT03118180 ↗ “CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB” NCT02935543 ↗ “combination therapy with CART-meso cells and CART19 cells” NCT02465983 ↗ “CART19 (CTL019) associated cytokine release syndrome” NCT02906371 ↗ |
| Known as | CTL019 | “monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for...” NCT02445222 ↗12“We found that ≥5 cycles of ibrutinib therapy improved the expansion of CD19-directed CAR T cells (CTL019), in association with decreased expression of the immunosuppressive...” PMID 26813675 ↗ Jan 2016 “This trial evaluates the CMR rate 12 weeks after tisagenlecleucel (CTL019) infusion, the incidence and severity of adverse events, progression-free survival, and overall...” NCT04161118 ↗ “The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel (CTL019) has an 81% response rate in children with relapsed or chemotherapy refractory (r/r) B-cell...” PMID 31815579 ↗ Dec 2019 “We used autologous T cells that express a CD19-directed CAR (CTL019) to treat patients with diffuse large B-cell lymphoma or follicular lymphoma that had relapsed or was...” PMID 29226764 ↗ Dec 2017 “CART19 (CTL019) associated cytokine release syndrome” NCT02906371 ↗ |
| Known as | huCART-19 | “Preclinical data suggesting synergy between CART-19 and the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib prompted us to conduct a prospective single-center phase 2 trial...” PMID 35349631 ↗ Nov 2022 |
| Known as | KYMRIAH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03642626 ↗ |
| Known as | tisa-cel | “The ELARA trial indicates tisagenlecleucel (tisa-cel) is an effective anti-CD19” PMID 35973192 ↗ Nov 2022 |
| Action | Deplete | “Chimeric antigen receptor-modified T-cell therapy against CD19 was effective in treating relapsed and refractory ALL.” PMID 25317870 ↗ Oct 2014 |
| Modality | Cell therapy | “The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel (CTL019)” PMID 31815579 ↗ Dec 2019 |
| Route | Intravenous | “administered as an IV infusion” NCT01029366 ↗ |
| Target | CD19 | “Chimeric antigen receptor-modified T cells targeting CD19 may overcome many limitations of conventional therapies and induce remission in patients with refractory disease.” PMID 25317870 ↗ Oct 2014 |