Myriad Genetics, Inc. (NASDAQ: MYGN) announced that it has submitted a supplementary premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) for its myChoice® CDx test to help predict outcomes of women with first-line platinum responsive advanced ovarian cancer treated with GSK's PARP inhibitor Zejula® (niraparib). Myriad's filing is based on the positive results from the Phase 3 PRIMA trial of Zejula that was published online in the New England Journal of Medicine in September 2019.
"The myChoice CDx test provides valuable molecular insights into tumors and helps identify women with ovarian cancer who are most likely to benefit from PARP inhibitors," said Nicole Lambert, president, Myriad Oncology. "This regulatory submission represents another important step forward for precision medicine and ensuring that women have access to the most advanced therapies."
Myriad's myChoice CDx is the most comprehensive homologous recombination deficiency test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice CDx test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions).