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FDA Approvals, News & UpdatesOvarian Cancer

Zejula Approved as Once-Daily Treatment Option in Women with Advanced Ovarian Cancer

Women with advanced ovarian cancer now have a new once-daily treatment option. In April 2020, the Food and Drug Administration (FDA) approved Zejula (niraparib) for the maintenance treatment of all women with advanced ovarian cancer (including epithelial cancer, fallopian tube cancer, and primary peritoneal cancer) who have responded well to first-line chemotherapy. Maintenance therapy is the treatment of cancer with medication, typically following a first round of treatment (in this case, platinum-based chemotherapy).
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Women with advanced ovarian cancer now have a new once-daily treatment option. In April 2020, the Food and Drug Administration (FDA) approved Zejula (niraparib) for the maintenance treatment of all women with advanced ovarian cancer (including epithelial cancer, fallopian tube cancer, and primary peritoneal cancer) who have responded well to first-line chemotherapy. Maintenance therapy is the treatment of cancer with medication, typically following a first round of treatment (in this case, platinum-based chemotherapy).

This approval includes all women with this type of advanced cancer, regardless of whether their tumors are positive for homologous recombination deficiency (HRD). Inherited mutations in the BRCA1 or BRCA2 genes are the most well-known mechanisms of HRD, and about 20% of ovarian cancers are caused by these mutations.

In 2020, it was estimated that 21,750 women would be diagnosed with ovarian cancer in the United States. More than half of patients diagnosed with ovarian cancer are diagnosed at a later stage when the disease has already spread to other parts of the body (metastasized). When the cancer is diagnosed at this advanced stage, only about 30% of women will still be alive 5 years after diagnosis.

Zejula is in a class of anticancer drugs called PARP inhibitors. These are targeted therapies that kill cancer by blocking cancerous cells from repairing their own damaged DNA. These drugs are commonly used to treat ovarian cancer, but in recent years, more effective treatments have been needed to improve survival for patients with advanced disease who are at an increased risk of disease progression after treatment with chemotherapy. The recent approval of Zejula as maintenance treatment for these patients helps to address that need; it is also the first PARP inhibitor to be approved by the FDA for the first-line maintenance treatment of all women with ovarian cancer, regardless of HRD-positive status or BRCA mutation.

This approval represents an expanded indication in ovarian cancer; the drug was already approved by the FDA in March 2017 for the treatment of ovarian cancer that has come back after successful treatment with platinum-based chemotherapy. Then, in October 2019, it received another indication for the treatment of women whose ovarian cancer came back after 3 or more chemotherapy regimens and whose tumors were HRD-positive; the latest approval includes all women with advanced ovarian cancer, regardless of their HRD status.

How to Take Zejula

Zejula is given by mouth in a 100-mg capsule. The recommended dose for the treatment of advanced ovarian cancer is 200 mg by mouth once a day for patients weighing less than 170 lb or with a platelet count of less than 150,000/μL, and 300 mg by mouth once daily for patients weighing 170 lb or more with a platelet count of ≥150,000/μL.

Zejula can be taken with or without food; it should be taken at about the same time each day, and the capsules should not be crushed, chewed, split, or dissolved. Taking this medication at bedtime may help relieve any nausea symptoms. If a dose is missed (or if taking the capsule led to vomiting), it should be taken the next day at the usual scheduled time. Patients should not take more of this medicine than they have been prescribed, even if attempting to make up for missed doses.

Treatment should be continued until the cancer gets worse or until the side effects of treatment become unmanageable. If treatment side effects do occur, interrupting the dose, reducing the dose, or stopping the dose completely may be required.

Before taking Zejula, patients should tell their doctor about any medical conditions, including any heart problems or high blood pressure, and should also tell their healthcare providers about any prescription and over-the-counter medicines they take, including vitamins and herbal supplements.

Potential Side Effects of Zejula

The most common side effects of Zejula include nausea, thrombocytopenia (a low number of platelets in the blood), anemia (not enough healthy red blood cells), feeling tired, constipation, musculoskeletal pain (pain affecting the bones, muscles, ligaments, tendons, and nerves), stomach pain, vomiting, low white blood cell count, decreased appetite, trouble sleeping, headache, shortness of breath, rash, diarrhea, high blood pressure, cough, dizziness, kidney injury, urinary tract infection, and electrolyte disturbance. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if these side effects are severe enough.

Women who are pregnant or plan to become pregnant should not take this drug because it can cause harm to an unborn baby or result in a miscarriage, so effective birth control should be used when taking this drug and for 6 months after the final dose. It is not known if this drug passes into the breast milk, so women should avoid breastfeeding during treatment and for 1 month after receiving their final dose (patients should talk with their healthcare provider about the best way to feed their baby during this time).

Some severe cases of myelodysplastic syndrome (MDS) and a cancer of the blood called acute myeloid leukemia (AML) have been reported in women receiving Zejula. MDS and AML may lead to death, so patients should be continuously monitored for blood toxicities, and treatment should be stopped if MDS or AML develop.

Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets), such as weakness, fever, feeling tired, and weight loss, are common during treatment with this drug, but they can be signs of serious bone marrow problems, including MDS or AML. To monitor for these potential effects, patients should receive blood count tests weekly for the first month of treatment with Zejula, once a month for the next 11 months, and as needed for the duration of treatment.

High blood pressure is common with Zejula, and it can become serious. Blood pressure and heart rate should be monitored at least once a week for the first 2 months of treatment, then monthly for the first year of treatment, and regularly thereafter for the duration of treatment. Blood pressure medication and/or adjusting the recommended dose of Zejula may be necessary for some patients.

Women considering this drug or taking this drug should know that these are not all of the possible side effects of Zejula, so patients should always tell their healthcare provider about any and all concerns.


Sarlis Says

Zejula was approved for maintenance therapy after successful first-line platinumbased chemotherapy in women with ovarian cancer. This drug has become the cornerstone for the earlier use of PARP inhibition, thereby increasing its potential to optimally control cancer growth during a patient’s treatment journey.

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Last modified: February 11, 2021

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