FDA okays Zejula for treatment of recurrent epithelial ovarian or fallopian tube or primary peritoneal cancers

zejula and recurrent ovarian cancer
zejula and recurrent ovarian cancer

Zejula (niraparib) gained FDA approval today for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk  in response to platinum-based chemotherapy.

Platinum-based chemotherapy is informally known as platins. About 50% of cancer patients are treated with these drugs. It’s believed that addition of platinum based chemotherapy drugs to chemoradiation intended for women with early cervical cancer can improve survival and reduce risk of recurrence. The problem with this type chemotherapy is neurotoxicity which can induce peripheral neuropathies.

Epithelial ovarian, fallopian tube or primary peritoneal cancer is a cancer of the tissue covering the ovary or lining the fallopian tube or abdominal wall (peritoneum). The National Cancer Institute estimates that more than 22,000 women will be diagnosed with these cancers in 2017 and more than 14,000 will die of these diseases.

Zejula is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.

Common side effects of Zejula include low levels of red blood cells (anemia), low levels of blood platelets (thrombocytopenia), low levels of white blood cells (neutropenia or leukopenia), heart palpitations, nausea, constipation, vomiting, abdominal pain/swelling (distention), inflammation of the mucous membranes (mucositis), diarrhea, indigestion (dyspepsia), dry mouth, fatigue, decreased appetite, urinary tract infection, liver problems (AST/ALT elevation), muscle pain (myalgia), back pain, joint pain (arthralgia), headache, dizziness, unusual taste sensation (dysgeusia), insomnia, anxiety, cold-like symptoms (nasopharyngitis), trouble breathing (dyspnea), cough, rash and high blood pressure (hypertension).

Zejula is associated with serious risks, such as hypertension, severe increase in blood pressure (hypertensive crisis), bone marrow problems (myelodysplastic syndrome), a type of cancer of the blood called acute myeloid leukemia and low levels of blood cells in the bone marrow (bone marrow suppression).

Women who are pregnant or breastfeeding should not take Zejula because it may cause harm to a developing fetus or a newborn baby.

For more information, please visit: FDA web site.


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