FDA Approves Zejula (Niraparib) for Ovarian Cancer

The US Food and Drug Administration (FDA) has approved the targeted therapy drug Zejula (niraparib) for women with some types of ovarian, fallopian tube, or peritoneal cancers. This is the third of this type of drug, called a PARP inhibitor, approved to treat women with ovarian cancer. But unlike with the other two drugs, the use of Zejula is not limited to women with a BRCA mutation. It’s approved for women whose cancer has come back after they received chemotherapy.

PARP inhibitors work by blocking an enzyme that helps repair damaged DNA. Blocking the enzyme helps keep cancer cells from repairing themselves, so that they are less likely to grow and more likely to die.

The FDA based its approval on a trial of 553 women with ovarian, fallopian tube, or peritoneal cancer that came back after at least 2 chemotherapy treatments, and that improved after the most recent treatment. The women were all tested to find out if they had a BRCA gene mutation. Women who have this inherited gene mutation have a higher risk for some cancers, including ovarian and breast cancers.

The trial measured the length of time after starting treatment that the women’s tumors did not grow, called progression-free survival. Those who had a BRCA mutation and received Zejula had an average progression-free survival of 21 months compared with 5.5 months for those who received a placebo (dummy pill). Those who had no BRCA mutation and received Zejula had an average progression-free survival of 9.3 months compared with 3.9 months for those who received a placebo.

Zejula was evaluated by the FDA using fast track, priority review, and breakthrough therapy designations – programs designed to speed up the availability of drugs to treat serious diseases. It was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

Zejula is a pill taken once a day. The most common side effects include low blood counts, heart palpitations, nausea and vomiting, constipation, diarrhea, abdominal pain and swelling, inflammation of the mucous membranes, indigestion, dry mouth, fatigue, decreased appetite, urinary tract infection, liver problems, muscle pain, back pain, joint pain, headache, dizziness, unusual taste sensation, insomnia, anxiety, cold-like symptoms, trouble breathing, cough, rash, and high blood pressure.

Zejula has also been linked to severe increases in blood pressure, a type of cancer of the blood called acute myeloid leukemia, and low levels of blood cells in the bone marrow. Women who are pregnant or breastfeeding should not take Zejula because it may harm a developing fetus or a newborn baby.

Zejula is marketed by Tesaro, Inc. 

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