The approval comes one day after the FDA approved niraparib for the same subset of ovarian cancer.
The myChoice CDx test, which detects homologous recombination (HRD+) status in advanced ovarian cancer by looking at BRCA gene variants, was approved by the US Food and Drug Administration (FDA). The approval came on the same day the FDA approved an immunotherapy (niraparib), to treat the HRD+ ovarian cancer.
The test detects genomic instability based on three factors: loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions, according to the test maker, the Utah-based Myriad Genetics.
The diagnostic approval follows 10 years of work in investigating markers for women who have been treated with 3 or more prior chemotherapy regimens, and whose disease is believed to be HRD+, according to the company.
“Women with advanced ovarian cancer who have had multiple rounds of chemotherapy have limited treatment options and today’s approval offers new hope,” said Nicole Lambert, the president of Myriad Oncology, adding the company wanted to make the test “widely accessible.”
The test was approved the same day as the FDA approval for niraparib (Zejula) in this subset of ovarian tumors. Niraparib, marketed by GlaxoSmithKline, was approved by the FDA for previously treated advanced ovarian, fallopian, or primary peritoneal cancers. The approval was specifically for HRD+ cancer previously treated with 3 or more chemotherapy regimens.
The approval of the drug is based on the single-arm QUADRA study, part of the results of which were published in The Lancet Oncology in May. The QUADRA study concluded that it was not only patients with BRCA mutation, but those without the genetic mutation, who could benefit.
“Our data support expansion of the treatment indication of poly (ADP-ribose) polymerase inhibitors to include patients with HRD-positive ovarian cancer beyond those with BRCA mutation,” the investigators wrote at the time.
Kathleen Moore, the QUADRA study’s lead investigator, of the Stephenson Cancer Center at the University of Oklahoma, said in a GSK statement that the new indication could help a subset of patients with “few or no options left.”
“Ovarian cancer has a high rate of recurrence, so there is a real need for therapies for women whose cancer has progressed through multiple lines of treatment and who have few or no options left,” said Moore. “It’s meaningful to see that Zejula has been approved as a late-line treatment for women including those with and without BRCA mutations.”
Moore K, Secord A, Geller M, et al. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1.