Myriad Genetics, Inc. Announces FDA Approval Of The MyChoice CDx Test As Companion Diagnostic For Zejula For Patients With Ovarian Cancer

Myriad Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the MyChoice CDx Test as the Companion Diagnostic (CDx) for Zejula (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer. This approval is based on final data from the PRIMA trial, where the MyChoice CDx Test determined homologous recombination deficiency (HRD) status and was used to stratify advanced ovarian cancer patients. The MyChoice CDx is the only FDA-approved companion diagnostic test in the United States to identify patients with HRD-positive status eligible for treatment with Zejula.

The test determines HRD status by leveraging next generation sequencing technology to conduct a comprehensive assessment of BRCA1/2 genes -- including large rearrangements -- and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST). Nearly 50% of patients with advanced ovarian cancer have HRD positive (HRD+) tumors. Identifying these patients is critical to ensuring appropriate use of PARP inhibitor therapy and improving personalized treatment decisions.

Zejula is a prescription medicine used for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer is associated with HRD+ status defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability. Zejula is used after the cancer has responded (complete or partial response) to treatment with first-line platinum-based chemotherapy. The MyChoice CDx Test determines HRD status by conducting a comprehensive assessment of BRCA1/2 genes and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST).

The MyChoice CDx Test can identify 34% more patients with HRD than other tumor tests that use % LOH alone. Zejula is an oral, once-daily poly (ADP ribose) polymerase (PARP) inhibitor that works by preventing DNA repair in tumor cells, ultimately leading to their death. Zejula is indicated in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

Zejula is also indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and who have been selected based on a US FDA-approved companion diagnostic for Zejula.