Myriad Genetics' myChoice CDx has received U.S. Food and Drug Administration (FDA) premarket approval as a companion diagnostic to guide the use of GlaxoSmithKline's poly (ADP-ribose) polymerase (PARP) inhibitor niraparib (Zejula) in a new indication for heavily pretreated ovarian cancer.
PARP inhibitors have become well-established in various lines of treatment for ovarian cancer. The latest approval for Zejula covers use in patients with advanced ovarian cancer after three or more prior chemotherapy regimens and who also test positive for homologous recombination deficiency (HRD). HRD is defined in one of two ways: by genomic instability with disease progression more than six months after a response to platinum-based chemotherapy treatment, or by a BRCA mutation that is deleterious or suspected to be deleterious. Zejula is the only PARP inhibitor with this particular indication in late-line ovarian cancer.
Myriad said in a statement that myChoice CDx is the only comprehensive test for HRD status based on the detection of BRCA1 and BRCA2 variants and biomarkers for genomic instability.
