HRD POSITIVE TRIAL

Additionally, the test is designed to determine Genomic Instability Score (GIS). The patientвЂ™s DNA sequences are then evaluated for changes in BRCA1 and BRCA2 genes. The lab isolates DNA from the patientвЂ™s tumor tissue and mixes with substances (called reagents) to create chemical reactions to determine DNA sequences. The doctor takes a small amount of cancer tissue from a patientвЂ™s tumor and sends it to a lab. When patients with ovarian cancer test positive for HRD, the doctor can determine if they are eligible for treatment with ZejulaВ® (niraparib). With a positive HRD status, a patientвЂ™s DNA is unable to repair. A positive HRD status means that there are mutations in BRAC1 and BRCA2 genes or a high Genomic Instability Score (GIS) in patients with ovarian cancer. What is it? The mењњhoice CDx is a laboratory test that detects homologous recombination deficiency (HRD) status. PMA Applicant: Myriad Genetic Laboratories, Inc.ДЄddress:В 320 Wakara Way, Salt Lake City, UT 84108 See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDAвЂ™s approval. Accessed May 13, 2020.This is a brief overview of information related to FDAвЂ™s approval to market this product. Lynparza (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer.

HRD POSITIVE TRIAL

вЂњTodayвЂ™s approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from Lynparza in combination with bevacizumab as a first-line maintenance treatment.вЂќ вЂњAdvances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer,вЂќ said Roy Baynes, MMed, PhD, FCP, chief medical officer of Merck Research Laboratories, in a statement. In the group receiving olaparib in addition to bevacizumab, additional AEs included diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%). Olaparib is the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations, in order to preferentially kill cancer cells.ДЄ biomarker subgroup analysis of 387 patients in the phase 3 PAOLA-1 trial found that in combination with bevacizumab, olaparib reduced the risk of disease progression or death by 67% and extended progression-free survival to a median of 37.2 months compared with 17.7 months in patients who received bevacizumab alone.ДЄmong the overall study population in the PAOLA-1 trial, the most common adverse events (AEs) included fatigue (53%), nausea (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). These mutations typically result in sensitivity to poly ADP ribose polymerase (PARP) inhibitors, such as olaparib. The HRD designation includes several genetic abnormalities, including BRCA mutations. According to the statement, BRCA1/2 mutations are found in approximately 22% of all ovarian cancers, and approximately 50% of ovarian cancers are HRD-positive. Women with ovarian cancer are often diagnosed with advanced disease, which has a 5-year survival rate of approximately 48%. Ovarian cancer is the fifth most common cause of death from cancer among women in the United States, according to a press release. Patients will be selected for the therapy based on an FDA-approved companion diagnostic for the drug. The FDA has approved olaparib in combination with bevacizumab as a first-line maintenance treatment for adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancers who saw a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.ДЄccording to a press release, HRD-positive status is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability.

Hrd-positive