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Find Oncology Drugs in Phase III Clinical Development

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            Lead Product(s): Darolutamide

            Therapeutic Area: Oncology

            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 January 31, 2020

            Details:

            The CHMP recommendation is based on the results of the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT.

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            Lead Product(s): Nivolumab,Ipilimumab

            Therapeutic Area: Oncology

            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 31, 2020

            Details:

            Company committed to first-line lung cancer patients in Europe, U.S. and other markets with planned filing of results from CheckMate -9LA.

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            Lead Product(s): Tucatinib,Trastuzumab,Capecitabine

            Therapeutic Area: Oncology

            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 January 31, 2020

            Details:

            First investigational therapy in a pivotal trial to include patients with metastatic HER2-positive breast cancer with active brain metastases.

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            Lead Product(s): APR-246,Azacitidine

            Therapeutic Area: Oncology

            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 January 30, 2020

            Details:

            Breakthrough Therapy Designation further supports Aprea Therapeutics's development program for APR-246 in combination with azacitidine in MDS patients with a TP53 mutation.

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            Lead Product(s): Cabozantinib

            Therapeutic Area: Oncology

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Takeda

            Deal Size: $86.0 million Upfront Cash: Undisclosed

            Deal Type: Partnership January 29, 2020

            Details:

            Submission based on two clinical trials in patients with advanced hepatocellular carcinoma who had received prior systemic therapy

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            Lead Product(s): Selpercatinib

            Therapeutic Area: Oncology

            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 January 29, 2020

            Details:

            The NDA is based on data from the LIBRETTO-001 Phase 1/2 trial in RET-altered lung and thyroid cancers.

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            Lead Product(s): Atezolizumab,Bevacizumab

            Therapeutic Area: Oncology

            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 27, 2020

            Details:

            This application is based on the results of the Phase III IMbrave150 study, which demonstrated that Tecentriq in combination with Avastin reduced the risk of death and the risk of disease worsening.

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            Lead Product(s): Acelarin,Cisplatin

            Therapeutic Area: Oncology

            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 January 27, 2020

            Details:

            The enrollment of patients in NuTide:121 follows U.S. Food and Drug Administration (FDA) clearance of the company's investigational new drug application (IND) for Acelarin.

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            Lead Product(s): Atezolizumab,Bevacizumab

            Therapeutic Area: Oncology

            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 27, 2020

            Details:

            The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe & effective treatments are available to patients.

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            Lead Product(s): Trifluridine,Tipiracil Hydrochloride

            Therapeutic Area: Oncology

            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 January 25, 2020

            Details:

            Data include pooled safety analysis of Phase III trials of LONSURF in patients with metastatic colorectal cancer and metastatic gastric junction cancer, updates on futibatinib trials in progress.

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