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Japanese Regulators Approve Lynparza for Ovarian, Prostate, Pancreatic Cancers

NEW YORK – The Japanese Ministry of Health, Labor, and Welfare has approved AstraZeneca's and MSD's olaparib (Lynparza) for molecularly defined subsets of patients with advanced ovarian, prostate, and pancreatic cancers.

Specifically, the drug is now available as a maintenance treatment for ovarian cancer patients with homologous recombination repair deficient (HRD) tumors after receiving first-line chemotherapy and bevacizumab (Genentech's Avastin); for BRCA1/2-mutated, metastatic castrate-resistant prostate cancer patients; and as a maintenance treatment after platinum chemo for BRCA1/2-mutated, unresectable pancreatic cancer patients.

Japanese regulators approved the drug in these settings based on data from three Phase III trials: PAOLA-1, PROfound, and POLO. "For patients in Japan diagnosed with each of these types of cancer there are very few treatment options," Roy Baynes, senior VP and head of global clinical development at MSD Research Laboratories, said in a statement. "Approvals for treatments such as Lynparza, the first PARP inhibitor to be approved in these specific types of metastatic castration-resistant prostate cancer and metastatic pancreatic cancer in Japan, enable us to advance this evolving era of personalized medicine and change how these cancers are treated."

In PAOLA-1, HRD-positive ovarian cancer patients had longer median progression-free survival on olaparib plus bevacizumab maintenance treatment compared to those on bevacizumab alone. In Japan, around 11,000 women were diagnosed with ovarian cancer this year, and 5,000 women died from the disease. An estimated 50 percent of ovarian cancer patients have HRD-positive tumors.

The US Food and Drug Administration approved the olaparib-bevacizumab combination for HRD-positive (defined as having BRCA1/2 mutations or genomic instability) advanced ovarian cancer patients in May this year. 

A subgroup analysis in PROfound showed that men with BRCA1/2-mutated metastatic castrate-resistant prostate cancer on olaparib had longer radiographic progression-free survival and overall survival than those on enzalutamide or abiraterone. There were more than 100,000 men in Japan this year newly diagnosed with prostate cancer, and on average those with metastatic castrate-resistant prostate cancer live for between nine and 13 months after diagnosis and have limited treatment options. The 12 percent of metastatic castrate-resistant prostate cancer patients with mutations in BRCA1 or BRCA2 tend to have an especially poor prognosis.

The FDA in May approved olaparib for metastatic castrate-resistant prostate cancer patients who have progressed on enzalutamide or abiraterone and have mutations in BRCA1/2 or in a range of other genes involved in HRD. The Japanese regulatory approval for olaparib in prostate cancer aligns with the narrower indication approved by the European Commission in November. 

In the POLO trial, BRCA1/2-mutated metastatic pancreatic cancer patients had a median progression-free survival of 7.4 months on olaparib versus 3.8 months on placebo. Olaparib reduced the risk of disease progression or death by 47 percent compared to placebo. In Japan, there were 44,000 new cases of pancreatic cancer this year and between 5 percent and 7 percent of those with metastatic disease have germline mutations in BRCA1 or BRCA2.

The FDA approved olaparib last year for this same indication based on data from the POLO trial.