FDA has approved the myChoice CDx test from Myriad Genetics, Salt Lake City, for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer 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 is a novel poly (ADP-ribose) polymerase (PARP) inhibitor jointly developed and commercialized by AstraZeneca, Cambridge, UK, and Merck, Kenilworth, NJ.
Nicole Lambert, Myriad Genetics.
“We congratulate AstraZeneca and Merck on obtaining another FDA approval of Lynparza for women with advanced ovarian cancer,” says Nicole Lambert, president of Myriad oncology and women’s health. “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.”
MyChoice CDx is a comprehensive HRD test that 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.
“Approval of the myChoice CDx test builds on our shared goal with Myriad to accelerate precision diagnosis and treatment for women with advanced ovarian cancer,” says Ruth March, senior vice president of precision medicine for AstraZeneca. “We are excited 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.”
For more information, visit Myriad Genetics.
