Japan

Chugai Pharmaceutical

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Chugai Obtains Approval for Additional Indication of Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Lead Product(s): Trastuzumab emtansine

Therapeutic Area: Oncology Product Name: Kadcyla

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 21, 2020

Details:

Approval is based on the study which evaluated the efficacy and safety of Kadcyla adjuvant therapy in patients with HER2-positive early breast cancer who did not have pathologic complete response following neoadjuvant therapy including Herceptin.

Astellas Pharma

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Gilteritinib Becomes First NICE-Approved Oral Therapy for Relapsed or Refractory Acute Myeloid Leukaemia

Lead Product(s): Gilteritinib

Therapeutic Area: Oncology Product Name: Xospata

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 16, 2020

Details:

With the submission of supplementary clinical data showing that gilteritinib demonstrated superior overall survival benefit compared to chemotherapy, increasing median OS from 5.6 months to 9.3 months.

Otsuka Pharmaceutical

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Otsuka Announces Simultaneous Regulatory Approvals by U.S. FDA and Health Canada of INQOVI

Lead Product(s): Cedazuridine,Decitabine

Therapeutic Area: Oncology Product Name: Inqovi

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 08, 2020

Details:

INQOVI is the first and only orally administered hypomethylating agent approved in the U.S. and Canada for the treatment of MDS and CMML.

Daiichi Sankyo Co Ltd

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EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer

Lead Product(s): Trastuzumab Deruxtecan

Therapeutic Area: Oncology Product Name: DS-8201

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2020

Details:

The MAA is based on the positive results from the pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2 regimens.

Astellas Pharma

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XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis

Lead Product(s): Enzalutamide

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

Details:

With this approval, XTANDI is now indicated for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.

Daiichi Sankyo Co Ltd

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Daiichi Sankyo Launches ENHERTU® in Japan for Patients with HER2 Positive Unresectable or Metastatic Breast Cancer

Lead Product(s): Trastuzumab Deruxtecan

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 25, 2020

Details:

ENHERTU is the second innovative oncology medicine to be launched in Japan from the oncology pipeline of Daiichi Sankyo in the past year.

Takeda Pharmaceutical

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U.S. FDA Approves Takeda’s ALUNBRIG as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer

Lead Product(s): Brigatinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

Long-term results from the Phase 3 ALTA 1L trial established alunbrig as a superior first-line treatment compared to Crizotinib for People with ALK+ Metastatic NSCLC, including those with Brain Metastases.

Takeda Pharmaceutical

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Takeda China Announces ADCETRIS® (Brentuximab Vedotin) ss Approved for the Treatment of Adult Patients with CD30-Positive Lymphomas

Lead Product(s): Brentuximab Vedotin,Cyclophosphamide,Doxorubicin HCl

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 15, 2020

Details:

Approval of ADCETRIS® (brentuximab vedotin) will provide new treatment option in China for patients diagnosed with relapsed or refractory system anaplastic large cell lymphoma (sALCL) or Hodgkin lymphoma.

Takeda Pharmaceutical

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European Commission Approves ADCETRIS for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma

Lead Product(s): Brentuximab Vedotin,Cyclophosphamide,Doxorubicin HCl

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 14, 2020

Details:

Approval is based on results of Phase 3 Echelon-2 Trial, which demonstrated treatment with Adcetris plus Chp (Cyclophosphamide, Doxorubicin, Prednisone) resulted in significant improvement in progression-free survival compared with a standard of care.

Astellas Pharma

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Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China

Lead Product(s): Gilteritinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 10, 2020

Details:

New drug application for XOSPATA, for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation, has been accepted by the NMPA for regulatory review in China.

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Chugai Pharmaceutical

Chugai Obtains Approval for Additional Indication of Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Astellas Pharma

Gilteritinib Becomes First NICE-Approved Oral Therapy for Relapsed or Refractory Acute Myeloid Leukaemia

Otsuka Pharmaceutical

Otsuka Announces Simultaneous Regulatory Approvals by U.S. FDA and Health Canada of INQOVI

Daiichi Sankyo Co Ltd

EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer

Astellas Pharma

XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis

Daiichi Sankyo Co Ltd

Daiichi Sankyo Launches ENHERTU® in Japan for Patients with HER2 Positive Unresectable or Metastatic Breast Cancer

Takeda Pharmaceutical

U.S. FDA Approves Takeda’s ALUNBRIG as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer

Takeda Pharmaceutical

Takeda China Announces ADCETRIS® (Brentuximab Vedotin) ss Approved for the Treatment of Adult Patients with CD30-Positive Lymphomas

Takeda Pharmaceutical

European Commission Approves ADCETRIS for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma

Astellas Pharma

Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China