Lynparza Approved in Japan to Treat Certain Advanced Ovarian Cancers

Lynparza Approved in Japan to Treat Certain Advanced Ovarian Cancers
Lynparza (olaparib) has been approved in Japan as a maintenance treatment for women with advanced ovarian cancer who responded to a first-line chemotherapy regimen containing bevacizumab, AstraZeneca and Merck announced in a press release. The approval, for patients whose cancer is positive for homologous recombination deficiency (HRD), is based on data from the PAOLA-1 Phase 3 trial (NCT02477644), in which oral Lynparza significantly extended the time patients lived without disease worsening by about 1.5 years. Similar approvals have also been granted in the U.S. and Europe. Regulators in Japan also approved Lynparza for two other cancer indications: people with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in the BRCA DNA repair genes, and as a maintenance treatment for BRCA-mutated inoperable pancreatic cancer. “For patients in Japan diagnosed with each of these types of cancer, there are very few treatment options," said Roy Baynes, MD, PhD, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories. "Approvals for treatments such as Lynparza ... enable us to advance this evolving era of personalized medicine and change how these cancers are treated,” added Baynes. Lynparza, an oral treatment developed by AstraZeneca and Merck (known as MSD outside North America), works by blocking the activity of PARP enzymes, which are involved in DNA repair. The therapy renders cancer cells more vulnerable to DNA damage, limiting their ability to grow and survive. HRD-positive tumors — those carrying mutations in the BRCA genes and/or exhibiting genomic instability (a high frequency of mutations within the genome) — often rely on the PARP enzyme to repair t
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