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On January 21, CDE's official website showed that AstraZeneca's application for the listing of new indications for the Olapali tablet was to be included in the priority review, a single drug used to treat adult patients with BRCA1/2 mutations (embryo and/or somatic cell line) who developed disease progression after previous new hormone therapy.
Olapali is the FDA-approved first oral polyaline disphosphate keruclease (PARP) inhibitor that kills tumor cells by inhibiting PARP enzyme activity and preventing PARP from dissociating from DNA, in collaboration with DNA damage repair functional defects.
first approved for listing in the European Union and the United States in 2014.
$1,198 million and $444 million, respectively, in 2019, according to the NewPharma database of the Rubik's Cube.
Olapali was first approved for listing by the NMPA in August 2018 and has been approved for treatment in China so far: (1) Maintenance therapy in adult patients with platinum-sensitive relapsed epitheliotic ovarian cancer, fallopian tube cancer or primary peritiotic cancer after platinum-containing chemotherapy has reached full or partial remission.
maintenance treatment for advanced ovarian cancer with BRCA mutation (2).
(3) maintenance therapy for advanced epitheliotic ovarian, fallopian or primary peritary cancer with BRCA mutations.
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