Canada Approves Lynparza for Metastatic CRPC Patients With Certain Gene Mutations

Canada Approves Lynparza for Metastatic CRPC Patients With Certain Gene Mutations
Canadian authorities have approved Lynparza (olaparib) as an oral treatment for people with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in BRCA or ATM genes, both of which are involved in DNA repair. The approval, granted under priority review, is specifically indicated for patients who progressed after treatment with new forms of hormone therapy, such as Xtandi (enzalutamide) or Zytiga (abiraterone acetate). It makes Lynparza the first PARP inhibitor approved for prostate cancer in Canada. "The risk of developing prostate cancer is significantly higher for carriers of the BRCA or ATM-gene mutation, which affects roughly 10 per cent of men living with mCRPC," Kim Chi, MD, at the University of British Columbia, said in a press release. "This new approval offers patients a much-needed new treatment option, and also reinforces the importance of BRCA and ATM testing," he said. Lynparza, jointly developed by AstraZeneca and MSD (known as Merck in North America), works by blocking the activity of PARP, an enzyme that is involved in DNA repair. The therapy renders cancer cells more vulnerable to DNA damage, which reduces their ability to grow and survive. This oral therapy is approved in the U.S. for men with mCRPC carrying mutations in their BRCA and ATM genes and also in the European Union for men with mCRPC and BRCA mutations. Canada’s approval was based on data from the PROfound Phase 3 clinical trial (NCT02987543), specifically from the 245 participants with mutations in the BRCA1, BRCA2, or ATM genes. Participants had experienced disease progression while receiving treatment with newer forms of hormone therapy, and were assigned randomly to receive Lynparza or an investigators’ choice of h
Subscribe or to access all post and page content.