Olaparib is the first PARP inhibitor approved in China for first-line maintenance treatment of germline and somatic BRCA mutated gynecological cancers.
Findings from three Phase III clinical trials suggest that PARP inhibitors may prolong disease-free survival in some advanced ovarian cancer patients without BRCA1/2 mutations.
Men with metastatic castration-resistant prostate cancer who had mutations in genes like BRCA1 and BRCA2 benefited from treatment with olaparib.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
The deal with AstraZeneca follows a licensing agreement signed earlier this year with Memorial Sloan Kettering Cancer Center also covering radionuclide PARP inhibitor IP.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The draft guidance recommends access to the drug through the Cancer Drugs Fund as maintenance therapy of advanced ovarian, fallopian tube, or primary peritoneal cancer.
The firm has joined forces with AstraZeneca, the IASLC, and the Global Lung Cancer Coalition, with a goal to double five-year survival rates by 2025.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.