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Details:
The disappointed outcome of the confirmatory trials leads to voluntarily withdraw, in the U.S., accelerated IMBRUVICA® (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma who have received at least one prior therapy and with marginal zone lymphoma.
Lead Product(s): Ibrutinib,Bendamustine Hydrochloride
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2023
EMWA 2024
Not Confirmed
Contact SupplierDetails:
The sNDA and NDA submissions were primarily based on results of three years of data from the Phase 1/2 iMAGINE clinical trial for Imbruvica (ibrutinib), blocks the BTK protein which showed an ORR of 78 percent and PK data was consistent with adult dosing of IMBRUVICA.
Lead Product(s): Ibrutinib
Therapeutic Area: Immunology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2022
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Ibrutinib plus venetoclax is an investigational fixed-duration combination. Patients received 3 cycles of ibrutinib lead-in followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp up to 400 mg/day PO).
Lead Product(s): Venetoclax,Ibrutinib
Therapeutic Area: Oncology Product Name: Venclexta
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Latest data from the CAPTIVATE study underscore that IMBRUVICA in an all-oral fixed-duration combination with venetoclax also delivers a high rate of progression-free survival at two years while enabling treatment-free remission for patients.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2021
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM.
Lead Product(s): Ibrutinib,Rituximab
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2020
EMWA 2024
Not Confirmed
Contact SupplierDetails:
The results show the ibrutinib plus venetoclax combination providing continued disease-free survival for CLL patients once treatment is complete.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2020
EMWA 2024
Not Confirmed
Contact SupplierDetails:
AbbVie will present updated results from the CAPTIVATE study, evaluating disease-free survival in previously untreated patients with chronic lymphocyctic leukemia/small lymphocytic leukemia who received ibrutinib (IMBRUVICA®) + venetoclax (VENCLEXTA®/ VENCLYXTO®) regimen.
Lead Product(s): Venetoclax,Ibrutinib
Therapeutic Area: Oncology Product Name: Venclexta
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Submission is based on results of more than five years of follow-up data from the Phase 3 iNNOVATE clinical trial evaluating IMBRUVICA in combination with rituximab for patients with WM. This is the longest follow-up data available for a BTK inhibitor in WM.
Lead Product(s): Ibrutinib,Rituximab
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2020
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Imbruvica (ibrutinib) is the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation, which is indicated for the treatment of chronic lymphocytic leukemia, Waldenström's macroglobulinemia & chronic graft versus host disease.
Lead Product(s): Ibrutinib
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Imbruvica (ibrutinib) is a USFDA approved Bruton’s tyrosine kinase inhibitor. It is being evaluated in combination with venetoclax for the treatment of relapsed/refractory mantle cell lymphoma.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2024
EMWA 2024
Not Confirmed
Contact SupplierDetails:
Imbruvica (ibrutinib) is a USFDA approved Bruton’s tyrosine kinase inhibitor. It is being evaluated in combination with venetoclax for the treatment of chronic lymphocytic leukemia.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2024
EMWA 2024
Not Confirmed
Contact SupplierDetails:
CA-4948 (emavusertib) is an IRAK4/FLT3/CLK inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of patients with Refractory Primary Central Nervous System Lymphoma.
Lead Product(s): Emavusertib,Ibrutinib
Therapeutic Area: Oncology Product Name: CA-4948
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2023
Details:
Breyanzi (lisocabtagene maraleucel) is a CD19-directed CAR T cell therapy, received EU approval for the treatment of adult patients with DLBCL, HGBCL, PMBCL and FL3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
Lead Product(s): Lisocabtagene Maraleucel,Ibrutinib
Therapeutic Area: Oncology Product Name: Breyanzi
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 November 09, 2023
Details:
Imbruvica (ibrutinib) is a small-molecule inhibitor of BTK, it was granted NICE approval in combination with venetoclax as first-line treatment option for chronic lymphocytic leukaemia.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2023
Details:
Breyanzi (lisocabtagene maraleucel) is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. It is approved by the U.S. FDA for the treatment of adult patients with large B-cell lymphoma (LBCL).
Lead Product(s): Lisocabtagene Maraleucel,Ibrutinib
Therapeutic Area: Oncology Product Name: Breyanzi
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2023
Details:
IMBRUVICA® (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.
Lead Product(s): Ibrutinib
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 12, 2022
Details:
IMBRUVICA® having Ibrutinib, blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pharmacyclics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2022
Details:
Zilovertamab (UC-961) continues to be evaluated in an ongoing Phase 1/2 study in combination with ibrutinib for the treatment of patients with MCL and chronic lymphocytic leukemia (CLL), and this trial was recently amended to include patients with marginal zone lymphoma.
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: UC-961
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
Patients with such an inadequate response (PR or SD) will be randomized (1:1) to receive zilovertamab (UC961) (600mg administered by IV every 2 weeks for 3 administrations and then every 4 weeks thereafter) or placebo, while continuing to receive oral ibrutinib.
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: UC961
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2022
Details:
IMBRUVICA® (ibrutinib) is a once-daily oral medication blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread.
Lead Product(s): Ibrutinib
Therapeutic Area: Immunology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pharmacyclics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2022
Details:
Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen and Pharmacyclics. Ibrutinib blocks the Bruton's tyrosine kinase protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2022
Details:
Under the terms of the collaboration, the supply of ibrutinib will support the company’s global registrational Phase 3 clinical trial of zilovertamab for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), ZILO-301.
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: UC961
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pharmacyclics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 14, 2022
Details:
The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the efficacy and safety of Imbruvica (ibrutinib) plus venetoclax in patients with previously untreated CLL.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2022
Details:
Updated data from Imbruvica (ibrutinib), FD cohort with three years of follow-up shows that I+V continues to demonstrated deep and durable responses and clinically meaningful progression-free survival and overall survival in the first-line treatment setting.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AbbVie Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
In preclinical research, VLS-101 (zilovertamab), an investigational monoclonal antibody designed to inhibit ROR1, a type I tyrosine kinase-like orphan receptor.demonstrated anti-tumor activity in a series of studies.
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: VLS-101
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Karolinska Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
VLS-101 (zilovertamab) is an investigational, humanized, potentially first-in-class monoclonal antibody targeting Receptor tyrosine kinase-like Orphan Receptor 1 (ROR1).
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: VLS-101
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 June 10, 2022
Details:
TakeAim Lymphoma data for the combination of CA-4948 (emavusertib) plus ibrutinib show tumor reduction in 8 of 9 evaluable patients, including 2 complete responses and 2 partial responses.
Lead Product(s): Emavusertib,Ibrutinib
Therapeutic Area: Oncology Product Name: CA-4948
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2022
Details:
With a median follow-up of 84.7 months, the IMBRUVICA (Ibrutinib) plus BR and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3-year improvement in median PFS.
Lead Product(s): Ibrutinib,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
ORR of 85% (23 of 27 evaluable patients) and CR rate of 41% (11 of 27 evaluable patients) for patients with MCL treated with VLS-101 (zilovertamab) plus ibrutinib compare favorably to historical ORR of 66% and CR of 20% for ibrutinib monotherapy.
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: VLS-101
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 May 26, 2022
Details:
The data from TakeAim Leukemia study are consistent with our findings demonstrated CA-4948 (emavusertib) encouraging monotherapy activity in patients with R/R AML and MDS including importantly those with spliceosome and FLT3 mutations.
Lead Product(s): Emavusertib,Ibrutinib
Therapeutic Area: Oncology Product Name: CA-4948
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
Data from preclinical studies with ME-401 (zandelisib), a selective PI3Kδ inhibitor, ex vivo in normal human T cells and in vivo in a murine CLL model suggest that zandelisib has immunomodulatory properties on human T cells.
Lead Product(s): Zandelisib,Ibrutinib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
Clinical proof of concept for X4P-001 (mavorixafor) in a Phase 2 trial of WHIM syndrome demonstrated reduction in severe neutropenia and significant lymphopenia; overall, mavorixafor was well tolerated.
Lead Product(s): Mavorixafor,Ibrutinib
Therapeutic Area: Oncology Product Name: X4P-001
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ibrutinib in combination with bendamustine and rituximab in adult patients with previously untreated mantle cell lymphoma.
Lead Product(s): Ibrutinib,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
The company reached consensus with the FDA on the design and major details of the Phase 3 superiority Study ZILO-301, to treat patients with relapsed or refractory MCL with VLS-101 (zilovertamab) plus Imbruvica (ibrutinib).
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: VLS-101
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 January 04, 2022
Details:
The combination of zilovertamab plus ibrutinib has been well tolerated, with treatment emergent adverse events consistent with those reported for ibrutinib alone. There have been no dose-limiting toxicities and no serious adverse events attributed to zilovertamab alone.
Lead Product(s): Zilovertamab,Ibrutinib
Therapeutic Area: Oncology Product Name: UC-961
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 December 13, 2021
Details:
YTB323, an investigational, autologous CD19-directed CAR-T cell therapy developed using the T-Charge platform, showed promising results in the diffuse large B-cell lymphoma arm of a first-in-human, multicenter, Phase I dose-escalation study.
Lead Product(s): YTB323,Ibrutinib
Therapeutic Area: Oncology Product Name: YTB323
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
Ibrutinib in an oral, once-daily fixed-duration combination with venetoclax outperformed a standard chemoimmunotherapy regimen for older or unfit patients, providing the first comparative evidence that this approach has the potential to improve depth of response.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2021
Details:
Patients in the I+V arm received three months of IMBRUVICA® lead-in therapy followed by 12 months of combination I+V therapy, and all patients stopped therapy regardless of MRD status.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2021
Details:
GLOW is part of a comprehensive development program exploring the potential of IMBRUVICA®-based fixed-duration therapy in previously untreated CLL.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2021
Details:
NATCO Pharma has received tentative approval for Abbreviated New Drug Application (ANDA) for Ibrutinib Tablets 560mg, 420mg, 280mg and 140mg strengths (generic for IMBRUVICA), from the U.S. Food and Drug Administration (USFDA).
Lead Product(s): Ibrutinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2021
Details:
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
Lead Product(s): Ibrutinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
Details:
First patient has been dosed in its Phase 1 trial evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in combination with ibrutinib, a BTK inhibitor, in patients with relapsed or refractory (R/R) hematologic malignancies.
Lead Product(s): CA-4948,Ibrutinib
Therapeutic Area: Oncology Product Name: CA-4948
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2021
Details:
ADC Therapeutics has initiated an expanded access program (EAP) for loncastuximab tesirine (Lonca, formerly ADCT-402) for patients in the U.S. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Lead Product(s): Loncastuximab Tesirine,Ibrutinib
Therapeutic Area: Oncology Product Name: Lonca
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 07, 2021
Details:
IMBRUVICA® pooled clinical trial analyses presented at ASH demonstrate sustained efficacy and safety in patients with historically poor outcomes.
Lead Product(s): Ibrutinib
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2020
Details:
New data from the Phase 2 CAPTIVATE study presented at ASH 2020 showed that 95% of patients with undetectable minimal residual disease randomised to discontinue active treatment after twelve cycles of treatment with IMBRUVICA plus venetoclax were disease-free after 12 months.
Lead Product(s): Ibrutinib,Venetoclax
Therapeutic Area: Oncology Product Name: Imbruvica
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2020
Details:
The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy.
Lead Product(s): Loncastuximab Tesirine,Ibrutinib
Therapeutic Area: Oncology Product Name: Lonca
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 20, 2020
Details:
When combined with ibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, the activity observed supports the potential for MALT1 inhibitors to be used in combination to overcome drug-induced resistance in patients with relapsed/refractory B-cell lymphoma.
Lead Product(s): Undisclosed,Ibrutinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
Eight abstracts have been selected for presentation at the 62nd ASH Annual Meeting. Presentations will feature data on three of the Company’s pyrrolobenzodiazepine (PBD)-based ADCs – loncastuximab tesirine (Lonca), camidanlumab tesirine (Cami) and ADCT-602.
Lead Product(s): Loncastuximab Tesirine,Ibrutinib
Therapeutic Area: Oncology Product Name: Lonca
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:
The paper explains preclinical work done to select CA-4948 and its on-target engagement and inhibition of IRAK4 in various animal studies. CA-4948 demonstrated potent IRAK4 inhibition, with favorable selectivity over other kinases, cellular activity, PK, efficacy, and safety.
Lead Product(s): CA-4948,Ibrutinib
Therapeutic Area: Oncology Product Name: CA-4948
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
X4 Pharmaceuticals expects to release initial data from a Phase Ib trial of mavorixafor for use in patients with Waldenstrom's macroglobulinemia in the first half of 2021.
Lead Product(s): Mavorixafor,Ibrutinib
Therapeutic Area: Oncology Product Name: X4P-001
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
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