Japan

Astellas Pharma

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JAPAN Japan

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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.

Takeda Pharmaceutical

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Takeda receives CHMP positive opinion for ADCETRIS in combination with CHP in the treatment large-scale anaplastic 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 April 01, 2020

Details:

Opinion based on the phase 3 ECHELON-2 study, demonstrating chemotherapy + ADCETRIS, resulted in a statistically significant improvement in progression-free survival compared to a standard of care.

Takeda Pharmaceutical

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Takeda Receives Positive CHMP Opinion for ADCETRIS in Combination with Cyclophosphamide, Doxorubicin and Prednisone

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 March 31, 2020

Details:

U.S. FDA has accepted for filing with Priority Review its recently submitted supplemental New Drug Application for the use of EPIDIOLEX CV to treat seizures in Tuberous Sclerosis Complex.

Nippon Shinyaku

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Nippon Shinyaku inks new agreement for prostate cancer treatment

Lead Product(s): Abiraterone Acetate

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Janssen Pharmaceutical K.K.

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement February 07, 2020

Details:

Under the agreement, both companies will start co-promoting ZYTIGA® to healthcare professionals in Japan from March 2, 2020, with Janssen retaining marketing authorization for ZYTIGA®.

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Companies

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

Takeda Pharmaceutical

Takeda receives CHMP positive opinion for ADCETRIS in combination with CHP in the treatment large-scale anaplastic lymphoma

Takeda Pharmaceutical

Takeda Receives Positive CHMP Opinion for ADCETRIS in Combination with Cyclophosphamide, Doxorubicin and Prednisone

Nippon Shinyaku

Nippon Shinyaku inks new agreement for prostate cancer treatment