AstraZeneca and Merck announced that Lynparza (olaparib) was approved for three more indications in Japan. The three new cancer indications approved were ovarian, prostate, and pancreatic cancer.
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Lynparza was approved in BRCA gene mutated castration-resistant prostate cancer, BRCA gene-mutated unresectable pancreatic cancer as maintenance therapy after platinum-based chemotherapy, and homologous recombination repair-deficient ovarian cancer after first-line chemotherapy.
The approvals were based on the PAOLA-1, PROfound, and POLO Phase 3 trials.
The approval for HRD-positive ovarian cancer was based on PAOLA-1 Phase 3 trial, in combination with bevacizumab. Lynparza showed improvement in the progression-free survival versus bevacizumab monotherapy. The median PFS was 37.2 months in Lynparza vs. 17.7 months in bevacizumab monotherapy.
The approval for BRCA mutated castration-resistant prostate cancer was based on the PROfound Phase 3 trial. Lynparza has shown improvement in progression-free survival and overall survival versus enzalutamide or abiraterone in men with BRCA1/2 mutations. Median rPFS was 9.8 months in Lynparza vs. 3.0 months in patients on enzalutamide or abiraterone.
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In POLO Phase 3 trial, Lynparza demonstrated significant PFS improvement versus placebo in patients with gBRCA mutated metastatic pancreatic cancer. Duration of patients without disease progression was also increased, with a median of 7.4 months in Nothe Lynparza arm vs. 3.8 months on the placebo arm.