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Details:
Data shows that after more than five years of median follow-up (65.4 months), PFS remained significantly superior among patients treated with the VENCLEXTA (Venetoclax) and obinutuzumab combination compared to the chlorambucil and obinutuzumab chemotherapy regimen.
Lead Product(s): Venetoclax,Obinutuzumab
Therapeutic Area: Oncology Product Name: Venclexta
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 10, 2022
RDD 2024
Not Confirmed
Contact SupplierDetails:
In addition, assessment in peripheral blood 30 months after the end of treatment showed that 26.9% of patients treated with VENCLEXTA (venetoclax) still had undetectable MRD (<10-4) compared with 3.2% of patients in the study arm who received obinutuzumab plus chlorambucil.
Lead Product(s): Venetoclax,Obinutuzumab
Therapeutic Area: Oncology Product Name: Venclexta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2021
RDD 2024
Not Confirmed
Contact SupplierDetails:
AbbVie to present data from the CLL14 trial evaluating venetoclax in combination with obinutuzumab in patients with previously-untreated CLL and Extended follow-up from subgroup-analyses of MURANO trial of venetoclax in combination with rituximab in relapsed/refractory CLL.
Lead Product(s): Venetoclax,Obinutuzumab
Therapeutic Area: Oncology Product Name: Undisclosed
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 May 14, 2020
RDD 2024
Not Confirmed
Contact SupplierDetails:
Columvi (glofitamab) is a CD20xCD3 T-cell engaging bispecific antibody, which is being evaluated in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: Columvi
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2024
Details:
Zynlonta (loncastuximab tesirine) is a CD19-directed antibody drug conjugate, which is being evaluated in combination with glofitamab & obinutuzumab for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma.
Lead Product(s): Loncastuximab Tesirine,Glofitamab,Obinutuzumab
Therapeutic Area: Oncology Product Name: Zynlonta
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2024
Details:
BeiGene has granted accelerated approval to Brukinsa (zanubrutinib), BTK Inhibitor for the treatment of adult patients with relapsed or refractory follicular lymphoma, in combination with the anti-CD20 monoclonal antibody obinutuzumab.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2024
Details:
Brukinsa (zanubrutinib) is a small molecule inhibitor of BTK. It is now approved by European Commision for the treatment of relapsed or refractory follicular lymphoma.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2023
Details:
Brukinsa (zanubrutinib), a bruton’s tyrosine kinase inhibitor (BTKi), is being developed in combination with obinutuzumab for the treatment of adult patients with R/R follicular lymphoma (FL). If approved, brukinsa will be the first and only BTKi approved for FL.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
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 October 13, 2023
Details:
Brukinsa (zanubrutinib) is a small-molecule inhibitor of BTK that is currently being developed in combination with obinutuzumab for the treament of adults with relapsed or refractory (R/R) follicular lymphoma and is approved for Mantle cell lymphoma.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
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 July 12, 2023
Details:
Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: Columvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 11, 2023
Details:
Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Glofitamab-gxbm,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: Columvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2023
Details:
Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: Columvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2023
Details:
Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: Columvi
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2023
Details:
RO7082859 (Glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells, activating the release of cancer cell-killing proteins from the T-cell.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: RO7082859
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 06, 2023
Details:
Calquence (acalabrutinib), a next-generation, selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 28, 2022
Details:
Gazyva (obinutuzumab), is a glycoengineered type II anti-CD20 monoclonal antibody designed to bind to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells.
Lead Product(s): Obinutuzumab,Chlorambucil
Therapeutic Area: Oncology Product Name: Gazyva
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Nippon Shinyaku
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2022
Details:
Glofitamab (RO7082859), is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: RO7082859
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 12, 2022
Details:
In the trials, results showed the CALQUENCE capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 05, 2022
Details:
Updated data from Phase III CLL14 study of Venclexta (venetoclax) plus Gazyva (obinutuzumab) showed more than 60% of previously untreated people with chronic lymphocytic leukemia remained in remission five years after starting treatment.
Lead Product(s): Venetoclax,Obinutuzumab
Therapeutic Area: Oncology Product Name: Venclexta
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 09, 2022
Details:
Updated data from ELEVATE-TN Phase III trial at five years, will highlight longer-term safety, PFS efficacy results and OS rates for Calquence (Acalabrutinib) in combination with obinutuzumab and alone compared to obinutuzumab plus chlorambucil in adults with CLL.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 09, 2022
Details:
Updated results from ELEVATE-TN trial showed CALQUENCE (acalabrutinib) maintained significant PFS versus chlorambucil plus obinutuzumab and safety and tolerability profile consistent with known profile for CALQUENCE at median follow up of five years in combination.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 04, 2022
Details:
At a median follow-up of 58.2 months, Calquence (Acalabrutinib) plus obinutuzumab reduced risk of disease progression or death by 89% and as a monotherapy by 79% (based on a HR of 0.21, 95% CI 0.15-0.30), compared with chlorambucil plus obinutuzumab.
Lead Product(s): Acalabrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Calquence
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 04, 2022
Details:
Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4.
Lead Product(s): Naptumomab Estafenatox,Docetaxel,Obinutuzumab
Therapeutic Area: Oncology Product Name: ABR-217620
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Translational Drug Development
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
Glofitamab is part of Roche’s industry-leading CD20xCD3 bispecific antibody development programme, which aims to address the diverse needs and preferences of people with blood cancers.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: RO7082859
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 27, 2022
Details:
Pivotal data on RO7082859 (glofitamab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with aggressive lymphoma, will be presented as part of our industry-leading haematology portfolio.
Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab
Therapeutic Area: Oncology Product Name: RO7082859
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 24, 2022
Details:
NKTR-255, an investigational IL-15 receptor agonist, enhances expression of NK cell-activating receptors, stimulates NK cell proliferation and sustains NK cell expansion, it also enhances anti-MCAM CAR NK cell cytotoxicity against sarcoma's and neuroblastoma in vitro.
Lead Product(s): NKTR-255,Obinutuzumab
Therapeutic Area: Oncology Product Name: NKTR-255
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Cairo Laboratory
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2022
Details:
The filing is based on results including Phase III ELEVATE-TN study evaluating efficacy and safety of Gazyva (obinutuzumab), a glycoengineered type II anti-CD20 monoclonal antibody and acalabrutinib bruton's tyrosine kinase inhibitor in patients with untreated CLL.
Lead Product(s): Obinutuzumab,Acalabrutinib
Therapeutic Area: Oncology Product Name: Gazyva
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Nippon Shinyaku
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
Incyte withdrawing NDA for INCB050465 (parsaclisib) for treatment of FL, MZL, and MCL which follow discussion with USFDA regarding confirmatory studies to support accelerated approval, which cannot be completed within time period, and opt-out of MCLA-145 development.
Lead Product(s): Parsaclisib,Rituximab,Obinutuzumab
Therapeutic Area: Oncology Product Name: INCB050465
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merus
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2022
Details:
The approval is based on the phase IV GAZELLE study investigating Gazyvaro in previously treated and untreated FL patients. The efficacy and safety of the GAZELLE study were consistent with that demonstrated by Gazyvaro administered at the regular rate of infusion.
Lead Product(s): Obinutuzumab
Therapeutic Area: Oncology Product Name: Gazyva
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
Long-term follow-up data from the CLL14 and MURANO studies support the primary analysis of Venclexta in chronic lymphocytic leukemia (CLL) and the possibility of tailoring treatment approaches based on genetic risk factors.
Lead Product(s): Venetoclax,Obinutuzumab
Therapeutic Area: Oncology Product Name: Venclexta
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 10, 2021
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