Myriad Genetics Submits First Module Of The Premarket Approval Application to FDA for myChoice® HRD CDx Test
Salt Lake City–Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized medicine, today announced that it has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its myChoice® HRD CDx test.
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.
About myChoice® HRD CDx
Myriad’s myChoice HRD CDx is the most comprehensive homologous recombination deficiency test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD test is a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions).
About Ovarian Cancer
Ovarian cancer affects approximately 22,000 women per year in the United States according to the American Cancer Society. Typically, ovarian cancer is diagnosed at later stages when it has metastasised to other areas of the body and only 20 percent of patients are diagnosed with early stage disease. Ovarian cancer is one of the deadliest cancers with approximately 14,000 deaths per year attributed to the disease. Patients with certain characteristics such as a family history of the disease, certain genetic mutations such as those in the BRCA1 and BRCA2 genes, obesity and endometriosis face a higher risk from ovarian cancer.
About Zejula® (Niraparib)
Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, Zejula concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with Zejula. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with Zejula. Discontinue Zejula if MDS/AML is confirmed. Zejula can cause fetal harm and females of reproductive potential should use effective contraception. Please see full U.S. prescribing information, including additional important safety information, available at www.zejula.com.
TESARO, a GlaxoSmithKline business, is commercializing ZEJULA. ZEJULA is a registered trademark of TESARO.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five strategic imperatives: build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.