Premarket FDA approval sought for myChoice HRD

Myriad Genetics is seeking FDA premarket approval for myChoice HRD as a test that can identify patients with ovarian, fallopian, or peritoneal cancer whose tumors are deficient in homologous recombination DNA repair, regardless of their BRCA mutation status, and may benefit from treatment with GSK’s niraparib (Zejula) as a fourth-line option. myChoice HRD detects whether patients have somatic mutations in BRCA1 and BRCA2 genes and other genomic scars through heterozygosity loss, telomeric allelic imbalance, and large-scale state transitions that make them unable to correct DNA damage and more likely to respond to DNA-damaging drugs.
The submission will include QUADRA study data, where the objective response rate was 28% and the median duration of response was 9.2 months in patients who received fourth and fifth-line treatment with niraparib, were platinum chemotherapy sensitive, and homologous recombination deficient by myChoice HRD. President of Myriad Oncology, Nicole Lambert, said: “In clinical studies, the myChoice HRD test effectively identified heavily pre-treated patients with ovarian, fallopian or primary peritoneal cancer who are likely to benefit from Zejula.”