Posted on December 29th, 2014 by
CancerConnect News: The U.S. Food and Drug Administration has granted accelerated approval to LynparzaTM (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes.
According to statistics from the American Cancer Society (ACS), ovarian cancer causes more deaths than any other cancer of the female reproductive system. The ACS estimates that in 2014 there will be approximately 22,000 new cases in the United States and almost 14,270 deaths related to ovarian cancer. The high death rate associated with ovarian cancer is largely attributed to the fact that the disease is often diagnosed once it has already become advanced, making effective treatment difficult.
LynparzaTM is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
The approval of LynparzaTM constitutes the first of a new class of drugs for treating ovarian cancer. LynparzaTM 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.
The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA mutations.
The new test is approved as a companion diagnostic, specifically to identify patients with advanced ovarian cancer who may be candidates for treatment with LynparzaTM
LynparzaTM efficacy was examined in a study where 137 participants with gBRCAm-associated ovarian cancer received the drug. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 34 percent of participants experienced ORR for an average of 7.9 months.
Common side effects of Lynparza included nausea, fatigue, vomiting, diarrhea, distorted taste (dysgeusia), indigestion (dyspepsia), headache, decreased appetite, common cold-like symptoms (nasopharyngitis), cough, joint paint (arthralgia), musculoskeletal pain, muscle pain (myalgia), back pain, rash (dermatitis) and abdominal pain. Serious side effects included the development of myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells; acute myeloid leukemia, a bone marrow cancer; and lung inflammation.
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