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AstraZeneca, Merck's Lynparza, Myriad Genetics' BRCA Test Approved in Japan

NEW YORK (GenomeWeb) – Japan's Pharmaceuticals and Medical Devices Agency has approved olaparib (Lynparza) as a first-line maintenance treatment after BRCA-mutated advanced ovarian cancer patients have responded to platinum-based chemotherapy.

Simultaneously, Myriad Genetics announced that Japanese regulators had also granted manufacturing and marking approval for its BRACAnalysis Diagnostic System, which is intended to be used to identify women with germline BRCA1/2 mutations who are most likely to benefit from olaparib. The Salt Lake City, Utah-based firm is commercializing BRACAnalysis in an exclusive partnership with SRL, a subsidiary of Japanese lab services provider Miraca Group.

For the approvals, AstraZeneca and Merck submitted to Japanese regulators data from the Phase III SOLO-1 trial, which involved 391 patients with BRCA1/2 mutations, high-grade serous or endometrioid ovarian cancer, who had complete or partial responses to chemotherapy upon entering the study and were randomized to olaparib or placebo for two years. Median PFS for patients on placebo was 13.8 months, while those receiving olaparib in the first-line setting hadn't reached the median of this endpoint at the time of data analysis. Researchers estimated that olaparib-treated patients could have median progression-free survival that's three years longer than the placebo group.

Japan's National Cancer Center estimates there are approximately 10,000 patients diagnosed with ovarian cancer each year. Studies have shown that around 44 percent of women who have a BRCA1 mutation and about 17 percent of those with a BRCA2 mutation will develop ovarian cancer in their lifetime. This is the first PARP inhibitor approved in Japan.

"Advances in understanding the role of BRCA mutations and PARP inhibition have fundamentally changed how physicians can treat this aggressive type of cancer," Roy Baynes, chief medical officer of Merck Research Laboratories, said in a statement. "With the approval of this new indication, patients in Japan with BRCA-mutated advanced ovarian cancer who respond to chemotherapy will have the opportunity to benefit from Lynparza in the first-line maintenance setting."

The European Commission also approved olaparib for this indication this week, while the US Food and Drug Administration's approval of this indication occurred in December 2018.