The Ministry of Food and Drug Safety approved MSD Korea to conduct a phase-3 clinical trial on Lynparza (olaparib), targeted therapy for ovarian cancer, to test a maintenance therapy.
A maintenance therapy helps a primary treatment succeed and prevent a relapse.
The study will evaluate a maintenance therapy using olaparib or placebo, after the first-line treatment of Lynparza plus Keytruda or Lynparza alone, in patients with progressive epithelial ovarian cancer (EOC) without BRCA (breast cancer gene) mutation.
The trial will be on 40 local patients at Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Severance Hospital, and Bundang Seoul National University Hospital.
MSD and AstraZeneca jointly developed Lynparza.
In Korea, the ovarian cancer treatment won approval for patients with BRCA mutation.
In more than 60 other countries, however, the medicine obtained a license as a treatment for recurrent ovarian cancer regardless of BRCA mutation.
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