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Find Oncology Drugs in Phase III Clinical Development in JAPAN

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            Lead Product(s): Lenvatinib,Pembrolizumab

            Therapeutic Area: Oncology Product Name: Lenvima

            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 November 10, 2020

            Details:

            CLEAR is a multi-center, randomized, open-label, Phase 3 trial evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib alone for the first-line treatment of patients with advanced RCC.

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            Lead Product(s): Enzalutamide

            Therapeutic Area: Oncology Product Name: Xtandi

            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 November 06, 2020

            Details:

            The approval is based on results from the PROSPER trial, a double-blind, placebo-controlled, pivotal Phase 3 trial that evaluated enzalutamide plus ADT versus placebo plus ADT in 1,401 men with nmCRPC and rapidly rising prostate-specific antigen levels.

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            Lead Product(s): Pevonedistat,Azacitidine

            Therapeutic Area: Oncology Product Name: MLN4924

            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 November 05, 2020

            Details:

            The company’s scientific research at ASH will identify unique approaches in advancing the treatment of hematologic cancers, illustrative of its commitment to developing and providing transformative solutions for patient needs.

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            Lead Product(s): Cabozantinib,Nivolumab

            Therapeutic Area: Oncology Product Name: Cabometyx

            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 October 27, 2020

            Details:

            Submission based on the CheckMate -9ER phase 3 pivotal trial, which showed CABOMETYX in combination with OPDIVO improved overall survival and doubled median progression-free survival and objective response rate versus sunitinib.

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            Lead Product(s): Atezolizumab,Cabozantinib

            Therapeutic Area: Oncology Product Name: Tecentriq

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Takeda Pharmaceutical

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration September 10, 2020

            Details:

            Subsequent to a joint clinical research agreement between Roche and Exelixis, Chugai and Takeda have decided to study Tecentriq® (atezolizumab) and CABOMETYX® (cabozantinib) combination therapy in Japan.

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            Lead Product(s): Nivolumab,Bevacizumab,Paclitaxel

            Therapeutic Area: Oncology Product Name: Opdivo

            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 August 03, 2020

            Details:

            This study is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical study evaluating Opdivo in combination treatment with bevacizumab and chemotherapy versus placebo in combination with bevacizumab and chemotherapy.

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            Lead Product(s): Pevonedistat,Azacitidine

            Therapeutic Area: Oncology Product Name: MLN4924

            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 July 30, 2020

            Details:

            The Breakthrough Therapy Designation is based on the final analysis of the Pevonedistat-2001 Phase 2 study, which evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including HR-MDS.

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            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.

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            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).

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            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.

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