Agency also gives OK to genetic test used to identify eligible patients
WebMD News from HealthDay
By Robert Preidt
HealthDay Reporter
FRIDAY, Dec. 19, 2014 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug to treat advanced ovarian cancer, along with a test to identify patients eligible to receive the drug.
Lynparza (olaparib) belongs to a new class of drugs called poly ADP-ribose polymerase (PARP) inhibitors. The drug is for women who have already received extensive treatment for advanced ovarian cancer associated with defective BRCA genes, according to an FDA news release issued Friday.
"Today's approval constitutes the first of a new class of drugs for treating ovarian cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in the news release.
"Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment," he said.
Approval of the AstraZeneca drug was based on a clinical trial of almost 140 women with BRCA mutation-associated ovarian cancer. Thirty-four percent of the patients on the drug had partial shrinkage or complete disappearance of their tumors for an average of eight months, the FDA reported.
Nausea, fatigue, vomiting, diarrhea, headache, decreased appetite, joint and muscle pain, and cold-like symptoms were common side effects of the drug. More serious side effects included lung inflammation; the bone marrow cancer acute myeloid leukemia; and myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells, the FDA said.
Women must undergo a genetic test to confirm BRCA gene mutations before they can be treated with Lynparza. The test to confirm those genes was approved by the FDA in conjunction with the drug.
BRCA genes play a role in repairing damaged DNA. Normally, they work to suppress tumor growth. Women with mutations that cause defective BRCA genes have an increased risk for ovarian and breast cancer. It's believed that 10 to 15 percent of all ovarian cancer is associated with these mutations, the FDA said.
In 2014, nearly 22,000 American women will be diagnosed with ovarian cancer and more than 14,000 will die from the disease, according to the U.S. National Cancer Institute.
source : FDA Approves First in New Class of Drugs for Advanced Ovarian Cancer
