FDA has approved myChoice CDx, from Myriad Genetics, Salt Lake City, for use by healthcare professionals as a companion diagnostic to identify women with advanced ovarian cancer who are candidates for Zejula (niraparib) in the late-line treatment setting. MyChoice CDx is the first FDA-approved tumor test for this indication.

The agency also approved an expanded indication for Zejula, from GlaxoSmithKline, Brentford, UK, for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer in patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency.

“Today’s approval marks a historic milestone for the myChoice CDx test after more than 10 years of development, and demonstrates Myriad’s commitment to pioneering science and collaboration with pharmaceutical partners in order to accelerate precision therapies for people with cancer,” says Jerry Lanchbury, PhD, chief scientific officer at Myriad Genetics.

MyChoice CDx is the first tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants with comprehensive assessment of genomic instability using three critical biomarkers: loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions.

“Women with advanced ovarian cancer who have had multiple rounds of chemotherapy have limited treatment options, and today’s approval offers new hope,” says Nicole Lambert, president of Myriad Oncology. “We look forward to working with the medical community to make the myChoice CDx test widely accessible and to help clinicians determine whether their patients are eligible for treatment with Zejula.”

Approximately 22,000 women are diagnosed with ovarian cancer each year in the United States. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the frontline, approximately 85% of patients will experience disease recurrence. Once the disease recurs, it is considered incurable, with time to each future recurrence getting shorter. Late-line treatment options for women with ovarian cancer are few, with the proportion of patients achieving an overall response typically less than 10% when treated with chemotherapy.

For more information, visit Myriad Genetics.

Featured image: BRCA2, a human gene and its protein product. Certain variations of the BRCA2 gene increase risks for cancer as part of a hereditary breast-ovarian cancer syndrome. Illustration © Ibreakstock courtesy Dreamstime (lD 84901062).