Oncology | Phase III Developments | JAPAN

Chugai Pharmaceutical

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Chugai Files a New Drug Application for Polatuzumab Vedotin for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Lead Product(s): Polatuzumab Vedotin,Rituximab,Cyclophosphamide

Therapeutic Area: Oncology Product Name: Polivy

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

This application is based on the results from a multicenter, single-arm Japanese phase II study that evaluated the efficacy and safety of the combination therapy of polatuzumab vedotin with bendamustine and rituximabin relapsed or refractory DLBCL.

Daiichi Sankyo Co Ltd

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Daiichi Sankyo Provides Update on CHMP Review of Pexidartinib, a CSF1R Inhibitor for the Treatment of Patients with TGCT

Lead Product(s): Pexidartinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2020

Details:

CHMP of the European Medicines Agency has adopted a negative opinion on the Marketing Authorization Application For pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumor (TGCT).

Takeda Pharmaceutical

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Takeda to Present Data at Upcoming Virtual Scientific Congresses, Underscoring Breadth of Oncology Portfolio and Emerging Pipeline

Lead Product(s): Pevonedistat,Azacitidine

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 14, 2020

Details:

Takeda will present data from its expanding oncology pipeline and established product portfolio at two upcoming scientific congresses: ASCO and EHA, that includes clinical data on Pevonedistat, ICLUSIG, NINLARO and among others.

Ono Pharmaceutical

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Positive Data in Hand, Ono/Takeda to Seek 1st-Line RCC Nod for Opdivo/Cabometyx Combo

Lead Product(s): Nivolumab,Cabozantinib,Ipilimumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2020

Details:

Opdivo and cabozantinib combination treatment demonstrated a significant benefit in its primary endpoint of progression-free survival (PFS) at final analysis, compared to sunitinib alone.

SymBio Pharmaceuticals

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Eagle Pharmaceuticals’ Japanese Licensing Partner SymBio Announces Completion of Clinical Trial Enrollment for TREAKISYM

Lead Product(s): Bendamustine

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2020

Details:

SymBio Pharmaceuticals Limited has completed patient enrollment in a clinical trial for TREAKISYM rapid infusion in Japan. Company plans to submit a New Drug Application for the product.

Takeda Pharmaceutical

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Takeda Provides Update on TOURMALINE-MM2 Phase 3 Trial

Lead Product(s): Ixazomib,Lenalidomide,Dexamethasone

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 10, 2020

Details:

The addition of ixazomib to lenalidomide and dexamethasone resulted in an improvement in median progression-free survival of 13.5 months; however, it did not meet the statistical significance.

Takeda Pharmaceutical

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Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG

Lead Product(s): Brigatinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2020

Details:

The sNDA is based on results from the Phase 3 ALTA-1L trial, which is evaluating the safety and efficacy of ALUNBRIG in patients with ALK+ locally advanced or metastatic NSCLC.

Chugai Pharmaceutical

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Chugai Files for Additional Indications of Tecentriq and Avastin for the Treatment of Unresectable Hepatocellular Carcinoma

Lead Product(s): Atezolizumab,Bevacizumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 14, 2020

Details:

The filing is based on the results from the global phase III IMbrave150 study in patients with unresectable HCC who have not received prior systemic therapy

Astellas Pharma

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XTANDI Improves Overall Survival in Phase III PROSPER Trial

Lead Product(s): Enzalutamide,Androgen deprivation therapy

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 11, 2020

Details:

The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT.

Ono Pharmaceutical

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ONO Announces Result from Phase III Clinical Study Evaluating Opdivo® (Nivolumab)nin Patients with Platinum-Refractory Advanced or Recurren...

Lead Product(s): Nivolumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 24, 2020

Details:

The monoclonal antibody, did not demonstrate a significant improvement in overall survival, a primary endpoint, versus chemotherapy in Patients.

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Find Oncology Drugs in Phase III Clinical Development in JAPAN

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Chugai Pharmaceutical

Chugai Files a New Drug Application for Polatuzumab Vedotin for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Daiichi Sankyo Co Ltd

Daiichi Sankyo Provides Update on CHMP Review of Pexidartinib, a CSF1R Inhibitor for the Treatment of Patients with TGCT

Takeda Pharmaceutical

Takeda to Present Data at Upcoming Virtual Scientific Congresses, Underscoring Breadth of Oncology Portfolio and Emerging Pipeline

Ono Pharmaceutical

Positive Data in Hand, Ono/Takeda to Seek 1st-Line RCC Nod for Opdivo/Cabometyx Combo

SymBio Pharmaceuticals

Eagle Pharmaceuticals’ Japanese Licensing Partner SymBio Announces Completion of Clinical Trial Enrollment for TREAKISYM

Takeda Pharmaceutical

Takeda Provides Update on TOURMALINE-MM2 Phase 3 Trial

Takeda Pharmaceutical

Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG

Chugai Pharmaceutical

Chugai Files for Additional Indications of Tecentriq and Avastin for the Treatment of Unresectable Hepatocellular Carcinoma

Astellas Pharma

XTANDI Improves Overall Survival in Phase III PROSPER Trial

Ono Pharmaceutical

ONO Announces Result from Phase III Clinical Study Evaluating Opdivo® (Nivolumab)nin Patients with Platinum-Refractory Advanced or Recurren...