Myriad Genetics Submits First Module of Premarket Approval Application to FDA for myChoice® HRD CDx Test

Myriad Genetics (NASDAQ:MYGN) has announced it has submitted the first module of its premarket approval (PMA) application to the US Food and Drug Administration (FDA) for the myChoice HRD CDx test.

As quoted in the press release:

Myriad is submitting myChoice HRD as a companion diagnostic for the identification of patients with ovarian, fallopian or primary peritoneal cancer who have received three or more lines of therapy and whose tumors harbor a BRCA mutation or are BRCA wild type yet are deficient in homologous recombination DNA repair and sensitive to their last round of platinum and could derive clinical benefit from treatment with the poly ADP ribose (PARP) inhibitor Zejula^® (niraparib).

“This submission of myChoice HRD CDx to the FDA is a major milestone for Myriad’s companion diagnostic program in oncology and our first indication for a tumor-based test,” said Nicole Lambert, president, Myriad Oncology.  “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.  We believe myChoice HRD CDx can help inform therapy selection and potentially improve outcomes for patients.”

The top-line finding from the QUADRA study, which will be the registration study used for Zejula in this indication, found that patients in the fourth and fifth line setting who were myChoice HRD positive and sensitive to their last platinum therapy, had a confirmed objective response rate of 28 percent (p=0.0005), which was highly statistically significant and a median duration of response of 9.2 months.

Click here to read the full press release.