A New Treatment In The Fight Against Ovarian Cancer

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iezahein A New TreatmentIn The Fight Against Ovarian Cancer (NAPSA)}—According to the American CancerSociety, a woman’srisk of developing ovarian canceris one in 73. Awarenessof the signs and symptomsof the disease is a woman’s first defense against it, but many of the symptomsof ovarian cancer are similar to those of everyday ailments,like bloating, pain in the abdomenorpelvis, and trouble eating or feeling full quickly. Because there are no tests for early detection of ovarian cancer, many women are only diagnosed whenthe disease has progressed to more advanced stages. For this reason, the Ovarian Cancer National Alliance (OCNA)lists ovarian cancer as the most deadly of all gynecological cancers, with a five-year survival rate of less than 50 percent. While early diagnosis is a barrier to improved survival, there havealso been very few treatments available to manage ovarian cancer in the advanced stages. Just recently, however, the U.S. Food and Drug Administration (FDA) has approved LYNPARZA”™(olaparib) capsules as a new treatment option. LYNPARZAis intended for use as monotherapy, meaning it can be used without any other treatment, in women living with advanced ovarian cancer described as deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) ovarian cancer, who have been treated with three or more prior lines of chemotherapy. The indication is approved under accelerated approval based on objective response rates and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatorytrials. “The FDA approval of LYNPARZA is important newsfor eligible women with germline BRCA-mutated (gBRCAm) advanced ovarian cancer,” said Dr. Briggs Morrison, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. Genetic Testing Different genes are linkedto different parts of the body, and these mutations can cause normalcells to become cancerous. Oneof the leading causes of ovarian canceris a genetic mutation that can be hereditary, known as BRCAI and BRCA2. Mutations in these genes can significantly increasetherisk of breast and ovarian cancer. According to the National Cancer Institute, of the 1.4 percentofall women who will develop ovarian cancer by 70 years of age, 39 percent will harbor a specific BRCAL mutation and 11 to 17 percent a BRCA2 mutation. It is also important to note that nearly half of women with ovarian cancer who have a BRCA mutation have no relevant family history of breast or ovarian cancer, whichis whyall women diagnosed with ovarian cancer should talk to their doctor about BRCA testing— 1 If you or someone you care about is at risk for ovarian cancer, your doctor may have a new wayto help. because it could help determine the course of treatment. Testing positive for a germline BRCA mutation is a requirement for treatment with LYNPARZA. Treatments that Target BRCA Mutations LYNPARZAis a type of drug knownas a PARPinhibitor (PARPi). A PARPi works by blocking the PARPprotein and thereby preventing DNArepairin cells. In BRCAmutated cancer cells, BRCA proteins are unable to effectively repair the DNA. Treatment with LYNPARZA can lead to a large buildup of DNA damagein cancercells, resulting in cancercell death. In clinical trials, LYNPARZA demonstrated an objective response rate (ORR)of 34 percent in patients with advanced gBRCAmutated ovarian cancer who received three or moreprior lines of chemotherapy. This means 34 percent of patients saw the size of their tumor shrink, versus those who saw no change. The median duration of therapy was found to be 7.9 months for patients involved in thetrial. LYNPARZA may cause serious side effects that can lead to death including bone marrow problems and lung problems. Patients will undergo blood tests before, and every month during, treatment with LYNPARZA to monitor their blood cell counts. The most commonsideeffects are anemia, nausea or vomiting, tiredness or weakness, diarrhea, indigestion or heartburn, headache, loss of appetite, changes in how food tastes, changes in kidney function blood tests, sore throat or runny nose, upper respiratory infection, cough, pain in the joints, muscles and back, rash, and pain or dis- comfort in the stomacharea. If you or someoneyouloveisliving with ovarian cancer, or if you have a family history of ovarian cancer, talk to your doctor about BRCA testing to determine if a genetic mutation is present. Once you know your genetic status, talk to your doctor about treatment options including whether a PARP inhibitor such as LYNPARZAis right for you. Please see the Important Safety Information below for additional information. Talk to your doctor about any questions you may haveabout ovarian cancer or LYNPARZA.To learn more, visit www.LYNPARZA.com. Important Safety Information There are no contraindications for LYNPARZA. LYNPARZAmay cause serious side effects that can lead to death including bone marrow problems and lung problems. Some people who have ovarian cancer or who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed bone marrow problems called Myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML) during treatment with LYNPARZA. Symptoms of low blood cell counts are common during treatment with LYNPARZA,but can be a sign of serious bone marrow problems, including MDS or AML. You will undergo blood tests before, and every month during, treatment with LYNPARZA to monitor your blood cell counts. Symptoms to discuss with your health care provider include weakness, weight loss, fever, frequent infections, blood in your urine/stool, shortness of breath, feeling very tired, and bruising or bleeding moreeasily. Tell your health care provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough or wheezing. Avoid pregnancy when taking LYNPARZAandtell your health care provider right away if you are, or think you have become, pregnant. Avoid grapefruit, grapefruit juice and Seville oranges during treatment as they may increase thelevels of LYNPARZAin yourblood. The most commonside effects are anemia, nausea or vomiting, tiredness or weakness, diarrhea, indigestion or heartburn, headache, loss of appetite, changes in how food tastes, changes in kidney function blood tests, sore throat or runny nose, upper respiratory infection, cough, pain in the joints, muscles, and back, rash, and pain or discomfort in the stomach area. For complete Product Information, including Patient Information (Medication Guide), visit www.LYNPARZA.com orcall 1-800-236-9933. Brought to you by AstraZeneca LYNPARZAis a registered trademark of the AstraZeneca group of companies. 2014 AstraZeneca