Japanese Ministry of Health, Labour, and Welfare has granted a second manufacturing and marketing approval for Myriad Genetics’ subsidiary, Myriad Genetic Laboratories, for BRACAnalysis Diagnostic System as a companion diagnostic with the PARP inhibitor, Lynparza, marketed by AstraZeneca and Merck.
BRACAnalysis can identify women with ovarian cancer who have a germline BRCA mutation and are eligible for first-line maintenance therapy with Lynparza. BRACAnalysis previously was approved in Japan for use in patients with unresectable or recurrent breast cancer and is the only companion diagnostic test for a PARP inhibitor to receive regulatory approval in Japan, Myriad noted.
“The approval of BRACAnalysis for women with ovarian cancer is a major milestone for precision oncology in Japan,” said Gary A. King, executive vice president of International Operations, Myriad Genetics. “We will work with our commercial partners in Japan to expand access to BRACAnalysis and Lynparza.”
Myriad will continue to commercialize BRACAnalysis in exclusive partnership with SRL Inc., a subsidiary of Miraca Group, and one of the largest laboratory service providers in Japan. According to Japan’s National Cancer Center, there are approximately 10,000 patients diagnosed with ovarian cancer each year.
“The new approval shows the need for women with ovarian cancer to receive a BRACAnalysis test at the time of diagnosis so they can know their treatment options,” said Professor Daisuke Aoki, M.D., Ph.D., Department of Obstetrics and Gynecology, Keio University School of Medicine and Chairperson of the Japan Society of Gynecologic Oncology. “Women who are found to carry a germline BRCA mutation are candidates for treatment with Lynparza.”
“The approval of BRACAnalysis as a companion diagnostic for Lynparza in women with ovarian cancer represents significant progress in delivering precision medicine to Japanese patients via our long-standing collaboration with Myriad Genetics Inc.,” said Ruth March, Ph.D., senior vice president and head of Precision Medicine, Oncology R&D, AstraZeneca.