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FDA Approves Myriad’s myChoice® CDx Test to Help Identify Women Eligible for Treatment with Zejula® in Late-line Ovarian Cancer
First FDA Approval Advances Precision Medicine for Women with Ovarian Cancer Who have Received Three or More Previous Chemotherapy Regimens SALT LAKE CITY,
About this update from Myriad Genetics, Inc.
[{"type":"text","content":"First FDA Approval Advances Precision Medicine for Women with Ovarian Cancer Who have Received Three or More Previous Chemotherapy Regimens\nSALT LAKE CITY, Oct. 23, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced that the U.S. Food and Drug Administration (FDA) approved myChoice® CDx for use as a companion diagnostic by healthcare professionals to identify women with advanced ovarian cancer who are candidates for Zejula® (niraparib) in the late-line treatment setting.\n GlaxoSmithKline also announced that it received approval from the FDA for an expanded indication for Zejula for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency. Today’s announcement marks the first FDA-approval for myChoice CDx, which is the only FDA-approved tumor test for this indication. “We congratulate GlaxoSmithKline on its FDA approval of Zejula for women with ovarian cancer,” said Jerry Lanchbury, Ph.D., chief scientific officer of Myriad. “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.” myChoice CDx is the first and only 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,” said Nicole Lambert, president of Myriad Oncology. “We look forward to working with the medical community to make the myChoice CDx test widely accessible and in helping clinicians determine whether their patients are eligible for treatment with Zejula.” Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States. Ovarian cancer is the fifth most frequen...