Myriad gets FDA approval of myChoice CDx as companion diagnostic for Lynparza

The U.S. Food and Drug Administration (FDA) approved the myChoice CDx test for use as a companion diagnostic by healthcare professionals to identify certaikn advanced ovarian cancer patients.

In particular, those patients with positive homologous recombination deficiency (HRD) status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab.

Lynparza (olaparib) is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca and Merck.

Nicole Lambert, president of Myriad Oncology and Women’s Health congratulated AstraZeneca and Merck on obtaining another FDA approval of Lynparza for women with advanced ovarian cancer. Lambert said that the approval of the myChoice CDx test will help clinicians quickly identify the potential one in two women whose ovarian cancer is HRD positive and who will likely respond to targeted therapy.

Myriad said in its press release that myChoice CDx is the most comprehensive HRD test and identifies people with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as PARP inhibitors. In the PAOLA-1 trial, which compared the efficacy of Lynparza in combination with bevacizumab versus bevacizumab alone, enrolled patients were tested by the myChoice CDx test, Myriad said.

Ruth March, senior vice president, Precision Medicine, AstraZeneca, said that the approval of the myChoice CDx test builds on AstraZeneca’s shared goal with Myriad to accelerate precision diagnosis and treatment for women with advanced ovarian cancer. March expressed excitement that women with advanced ovarian cancer who test positive for HRD with the myChoice CDx test at time of diagnosis can now access Lynparza in the first-line maintenance treatment setting in combination with bevacizumab.

Myriad noted it has been collaborating with AstraZeneca since 2007 on the development of companion diagnostics for Lynparza.