US FDA Approves a New Force in the Fight Against Ovarian Cancer
One of the leading causes of ovarian cancer is an inherited genetic mutation in one of two genes known as BRCA1 and BRCA2. Of the 1.4 percent of all women who will develop ovarian cancer by 70 years of age, 39 percent will have a BRCA1 mutation and 11 to 17 percent a BRCA2 mutation.
Currently there is no test for early detection of ovarian cancer and many cases are discovered only after the cancer has progressed to an advanced stage, as many symptoms, such as bloating, abdominal or pelvic pain and trouble eating, are similar to those of everyday ailments. While the first defense against ovarian cancer is being aware of the symptoms, AstraZeneca has a new option to aid women with BRCA mutated (as detected by an FDA- approved test) advanced ovarian cancer who have had three or more rounds of chemotherapy fight against this disease.
The U.S. Food and Drug Administration (FDA) has approved LYNPARZA™ (olaparib) capsules as a new treatment option. It is intended for use as monotherapy, meaning it can be used without any other concurrent 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 (3L+) 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 confirmatory trials. The most common side 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. See below for Important Safety Information.
LYNPARZA is the first approved PARP inhibitor for patients with gBRCA-mutated advanced ovarian cancer.
BRCA testing is required to determine eligibility for treatment with LYNPARZA, and major guidelines recommend that all patients with ovarian cancer be considered for BRCA testing. The Society of Gynecologic Oncology recommends that all women with ovarian cancer get tested for a BRCA mutation, because the results may impact future treatment decisions.
The approval of LYNPARZA strengthens AstraZeneca’s existing and growing oncology portfolio and reflects our ongoing commitment to fulfilling unmet needs in the gynecologic cancer community. Talk to your doctor about your own risks, and the possible benefits of genetic testing for you and your family.
Important Safety Information
There are no contraindications for LYNPARZA.
LYNPARZA may 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 healthcare provider include weakness, weight loss, fever, frequent infections, blood in your urine/stool, shortness of breath, feeling very tired, and bruising or bleeding more easily.
Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing.
Avoid pregnancy when taking LYNPARZA and tell your healthcare 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 the levels of LYNPARZA in your blood.
Click [here] for full Prescribing Information, including Patient Information (Medication Guide).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088
3064817 Last Updated 12/14