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Details:
Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of relapsed/refractory large b-cell lymphoma.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Details:
Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. It is indicated for treating relapsed/refractory large B-cell lymphoma.
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
YIKAIDA (axicabtagene ciloleucel injection) is an autologous CD19-targeted CAR T-cell therapy that was authorized to be locally produced in China using Yescarta® technology from Kite Pharma, Inc.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yikaida
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2023
Details:
Under the agreement, Kite obtains marketing authorization in Japan for Yescarta® (axicabtagene ciloleucel), a CAR T-cell therapy, and is approved in Japan for the treatment of patients with relapsed or refractory large B-cell lymphomas, a type of non-Hodgkin lymphoma.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: $250.0 million Upfront Cash: $50.0 million
Deal Type: Licensing Agreement June 22, 2023
Details:
Yescarta ® (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. It is indicated for treating relapsed/refractory large B-cell lymphoma.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2023
Details:
Yescarta (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight cancer.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2022
Details:
Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2022
Details:
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2022
Details:
YESCARTA® (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight cancer.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: $250.0 million Upfront Cash: $50.0 million
Deal Type: Licensing Agreement December 07, 2022
Details:
YIKAIDA (axicabtagene ciloleucel injection) is an autologous CD19-targeted CAR T-cell therapy that was authorized to be locally produced in China using Yescarta® technology from Kite Pharma, Inc.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yikaida
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
Yescarta (axicabtagene ciloleucel),the first Chimeric Antigen Receptor (CAR) T-cell therapy had a four-fold greater improvement in the primary endpoint of event-free survival (EFS; hazard ratio 0.40; 95% CI: 0.31-0.51, P<0.001) over the current SOC (8.3 months vs 2.0 months).
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2022
Details:
The positive opinion for Yescarta (axicabtagene ciloleucel) is based on the primary results of the landmark Phase 3 ZUMA-7 study, the largest and longest trial of a CAR T-cell therapy versus standard of care (SOC) in second-line LBCL.
Lead Product(s): Axicabtagene Ciloleucel,Fludarabine Phosphate,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2022
Details:
Pivotal ZUMA-5 Study for Yescarta® (axicabtagene ciloleucel) demonstrated overall response rate of 91% and a complete response rate of 77% in patients who received Yescarta after three or more lines of therapy.
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Details:
Patients aged 65+ had over three-fold improvement in two-year event-free survival (EFS) rate, and over eight-fold greater median EFS and clinically meaningful improvements in quality of life (QOL) with Yescarta (Axicabtagene Ciloleucel) vs SOC.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2022
Details:
Yescarta® (axicabtagene ciloleucel), is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
Landmark Zuma-7 study demonstrated patients on Yescarta, (axicabtagene ciloleucel) were 2.5 times more likely to be alive at two years without cancer progression or need for additional cancer treatment.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Details:
Yescarta was the first CAR T-cell therapy to be approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2022
Details:
Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Lead Product(s): Axicabtagene Ciloleucel,Fludarabine Phosphate,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2021
Details:
After a single infusion of Yescarta, 89% of evaluable patients achieved a response (ORR) (n=37 evaluable for efficacy), including 78% of patients with a complete response (CR) at a median follow-up of 15.9 months.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2021
Details:
Top-line results from the primary analysis of ZUMA-7 were recently reported and showed superiority of Yescarta compared to standard of care (SOC) in second-line relapsed or refractory LBCL.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
NDA approval is based on results of a single-arm, open label, multi-center bridging trial which has evaluated and proven the efficacy and safety of Axicabtagene Ciloleucel (FKC876) in the treatment of Chinese patients with refractory intermediate invasive DLBCL.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2021
Details:
Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR T-cell therapy manufactured in China under a license to YESCARTA® (Axicabtagene Ciloleucel) from Kite.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2021
Details:
In a weighted analysis comparing ZUMA-5 patients with a minimum of 18 months follow-up with those observed in SCHOLAR-5, an external control cohort, Yescarta demonstrated superior OS and PFS over currently available treatments.
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2021
Details:
At the recommended Phase 2 dose, lenzilumab in combination with CAR-T, demonstrated a 100% objective response rate (ORR) and no severe cytokine release syndrome or severe neurotoxicity.
Lead Product(s): Lenzilumab,Axicabtagene Ciloleucel,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Humaneered
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
Details:
Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third indication for a kite cell therapy. 91 percent of patients responded to yescarta, and median duration of response was not yet reached in the ZUMA-5 Trial.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2021
Details:
The approval of YESCARTA in Japan is based on ZUMA-1 trial conducted by Kite and results of a phase 2 study conducted by Daiichi Sankyo in Japan. The overall safety and tolerability profile of YESCARTA in the Japan trial was consistent with that observed in ZUMA-1.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2021
Details:
After a single infusion of Yescarta, 92 percent of iNHL patients (n=104 evaluable for efficacy) responded, including 76 percent of patients achieving a complete response (CR) at a median follow-up of 17.5 months.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2020
Details:
Among Yescarta-treated patients (modified intent to-treat analysis, n=101) with a minimum follow-up of four years after a single infusion of Yescarta (median follow-up of 51.1 months), the Kaplan-Meier estimate of the four-year overall survival (OS) rate was 44 percent.
Lead Product(s): Axicabtagene Ciloleucel,Fludarabine Phosphate,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2020
Details:
In the current trial, dubbed ZUMA-5, investigators administered axi-cel to 146 patients with follicular lymphoma or marginal zone lymphoma-two slow-growing forms of non-Hodgkin leukemia-at multiple U.S. medical centers.
Lead Product(s): Axicabtagene Ciloleucel,Fludarabine Phosphate,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2020
Details:
ZUMA-19 is a joint Humanigen/Kite clinical study that is being in the US. The Phase 1b/2 multicenter study is evaluating lenzilumab in adults with relapsed/refractory large B-cell lymphoma who are receiving CAR-T cell therapy with axicabtagene ciloleucel.
Lead Product(s): Lenzilumab,Axicabtagene Ciloleucel,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Humaneered
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
Yescarta is the first CAR T therapy approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Phase IVProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
U.S. Food and Drug Administration (FDA) for Yescarta® (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy.
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Yescarta
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 04, 2020
Details:
93 percent of patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma responded to a single infusion of Yescarta, with 80 percent achieving a complete response.
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
Details:
NDA submission based on previous pivotal trial data and a phase 2 study in Japan in patients with certain relapsed/refractory B-cell lymphomas.
Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Details:
The NDA filing is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876.
Lead Product(s): Axicabtagene Ciloleucel,Cyclophosphamide,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2020
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