Lynparza was approved for three more indications in Japan
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.
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.