FDA Approves Lynparza Combo as First-line Maintenance Therapy for Advanced Ovarian Cancer

FDA Approves Lynparza Combo as First-line Maintenance Therapy for Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has approved Lynparza (olaparib), in combination with bevacizumab, as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. This indication also includes patients who have advanced fallopian tube or primary peritoneal cancer. HRD-positive tumors — present in one of every two women with advanced ovarian cancer — have mutations in certain genes involved in DNA repair, including the BRCA genes, and/or genomic instability (a high frequency of mutations within the genome). Since these tumors rely on other DNA repair mechanisms mainly involving the PARP enzyme — a DNA damage sensor — they are more likely to respond to therapies blocking PARP activity (PARP inhibitors), such as Lynparza. Patients’ eligibility for this combination therapy will be evaluated using the Myriad myChoice CDx test, which was simultaneously approved by the FDA as a companion diagnostic to identify these DNA repair defects in tumors. This is now the fourth FDA-approved indication for Lynparza, an oral treatment developed by AstraZeneca and Merck (known as MSD outside the U.S. and Canada). The previous three approvals include first-line maintenance therapy and late-line treatment for women with BRCA-mutated advanced ovarian cancer, as well as late-line maintenance therapy for those with recurrent ovarian cancer, regardless of BRCA mutations. “This approval represents another milestone for Lynparza in patients with ovarian cancer," Dave Fredrickson, AstraZeneca’s executive vice president and head of the oncology business unit, said in a press release. The combination therapy also is being re
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