The Federal Drug Administration sign-off indicates that regulators believe Zejula’s can delay cancer growth in patients who have shown a complete or partial response to platinum-based chemotherapy.
“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” the FDA’s Richard Pazdur, MD, said in a press release. “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation.”
Pazdur is acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. He is also director of the FDA’s Oncology Center of Excellence.
The National Cancer Institute estimates that in 2017 more than 22,000 women will be diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer, and more than 14,000 patients will die of those cancers.
Zejula, is an oral, once-a-day poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor. It the only one of this class of drugs the FDA has approved as a maintenance therapy for women with recurrent ovarian, fallopian, or primary peritoneal cancers.
Zejula’s effectiveness and safety were evaluated in a double-blind, placebo-controlled, international Phase 3 trial known as NOVA (NCT01847274).
It covered 553 ovarian cancer patients with BRCA mutations or high-grade tumors who responded to platinum-based chemotherapy, which triggers errors in DNA. The participants had had at least two of the chemotherapy regimens.
The patients were given an FDA-approved test to determine whether they had a gene mutation called a deleterious or germline BRCA mutation.
Zejula significantly prolonged the time it took for patients’ disease to progress, compared with patients who took placebos. This was true both in patients with BRCA or other mutations in DNA repair genes, and in patients without mutations.
Median progression-free survival (PFS) for BRCA-positive patients who received Zejula was 21 months, versus 5.5 months in the placebo group. The median for patients without germline BRCA mutations who received Zejula was 9.3 months, compared with 3.9 months in the placebo-treated patients.
Zejula can cause adverse side effects, including back, muscle, or joint pain, headache, dizziness, dry mouth, fatigue, and low levels of blood cells. It also can cause hypertension, a severe increase in blood pressure, bone marrow problems, acute myeloid leukemia, and low levels of blood cells in the bone marrow. The list of other side effects that can occur include vomiting, cough, rash, nausea, constipation, and insomnia.
Zejula should not be taken by pregnant women.