The U.S. National Cancer Institute estimates that for 2014 alone, almost 22,000 American women will be diagnosed with ovarian cancer. Of these patients, over 14,000 will die from the condition.
For those with ovarian cancer with hereditary gene mutations, a new treatment option will soon become available, with health regulators greenlighting AstraZeneca's new ovarian cancer drug.
The Food and Drug Administration (FDA) gave the go signal for Lynparza (olaparib) as treatment for advanced ovarian cancer linked with mutations in the BRCA genes. In a clinical trial, the drug was found to shrink and even remove ovarian tumors in patients who have already undergone at least three lines of chemotherapy.
Lynparza was greenlighted with a companion diagnostic, a genetic test dubbed BRACAnalysis CDx designed to detect the presence of mutations in the BRCA genes (gBRCAm), which play a role in repairing damaged DNA and, under normal conditions, suppress tumor growth.
Women who have defective BRCA genes have increased likelihood of developing ovarian cancer. Between 10 and 15 percent of ovarian cancer cases also involve this type of genetic defect.
The newly approved drug is the first of a new class of drugs known as poly ADP-ribose polymerase (PARP) inhibitors, which block enzymes that help repair damaged DNA. Blocking this enzyme can lead to cell death in certain tumor cells, including those found in BRCA1 and BRCA2 mutation carriers.
"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," said Richard Pazdur from FDA's Center for Drug Evaluation and Research
The efficacy of Lynparza was evaluated in a study involving 137 individuals with gBRCAm-associated ovarian cancer, and the results showed that 34 percent of these individuals experienced partial shrinkage or total disappearance of the tumor for an average period of 7.9 months.
"This drug is working in a fundamentally different way [from] chemotherapy: this is a cancer treatment that's been designed to hit this kind of inherited genetic weakness in the cancer itself," said medical oncologist M. William Audeh from the Cedars-Sinai Medical Center.
Common side effects observed included indigestion, headache, loss of appetite, nausea, fatigue, vomiting, diarrhea and distorted taste. Prevalent laboratory abnormalities included a rise in the average volume of the red blood cells, reduced red blood cell count, decreased platelet level and increased creatinine.