New drug indication approval - September 2022
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Product Name
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LYNPARZA FILM-COATED TABLET 100MG, 150MG
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Active Ingredient
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Olaparib
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Product Registrant
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AZTRAZENECA SINGAPORE PTE LTD
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Date of Approval
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09/09/2022
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Indications:
Lynparza is indicated for the adjuvant treatment of adult patients with germline BRCA-mutated HER2-negative high risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy.
*Evaluated as part of Project Orbis
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Product Name
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NERLYNX FILM-COATED TABLETS 40 MG
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Active Ingredient
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Neratinib
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Product Registrant
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SPECIALISED THERAPEUTICS ASIA PTE LTD
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Date of Approval
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14/09/2022
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Indications:
Advanced or Metastatic Breast Cancer
NERLYNX in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting [see Clinical Studies (14.2)].
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Product Name
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NUBEQA FILM COATED TABLETS 300MG
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Active Ingredient
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Darolutamide
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Product Registrant
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BAYER (SOUTH EAST ASIA) PTE LTD
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Date of Approval
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26/09/2022
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Indications:
NUBEQA is indicated for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
*Evaluated as part of Project Orbis
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Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals