Tesaro Announces FDA Approval Of Zejula For Women With Recurrent Ovarian Cancer

(RTTNews) - Tesaro Inc. (TSRO) said Monday that the U.S. Food and Drug Administration has approved Zejula or niraparib, an oral, once-daily poly or ADP-ribose polymerase or PARP inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. It anticipates launching ZEJULA in the United States in late April.

ZEJULA is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing.

TSRO closed Monday's regular trading at $156.73 down $3.27 or 2.04%. But, in the after-hours, the stock gained $9.27 or 5.91%.

The safety and efficacy of Zejula were studied in a randomized trial of 553 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who had received at least two prior treatments of platinum-based chemotherapy and who had experienced a complete or partial response to their most recent chemotherapy treatment. Patients were tested with an FDA-approved test to determine whether they had a specific gene mutation, called a deleterious or germline BRCA mutation.

The trial measured the length of time the patients' tumors did not grow after treatment (progression-free survival) in patients with and without the mutation. The median progression-free survival for patients taking Zejula who had a germline BRCA mutation was 21 months compared to 5.5 months for the same patient population taking a placebo. The median progression-free survival for patients taking Zejula who did not have a germline BRCA mutation was 9.3 months compared to 3.9 months for the same patient population taking a placebo.

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.