Japan has approved its first PARP inhibitor in Lynparza for the treatment of advanced ovarian cancer, AstraZeneca and Merck have confirmed.
The approval was granted on the basis of two randomised trials of Lynparza maintenance therapy for platinum-sensitive relapsed ovarian cancer, SOLO-2 and Study 19.
“We are proud to bring this important first-in-class treatment to women with platinum-sensitive relapsed ovarian cancer in Japan who currently have very few treatment options,” said Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca.
“The trials show that with Lynparza maintenance therapy, women with ovarian cancer can live longer without their disease worsening and Lynparza is well tolerated.”
This latest approval follows news that Lynparza became the first and only PARP indicator for se beyond ovarian cancer after gaining approval by the US FDA.