Medication Monitor

Generic Name (Trade Name—Company)
October 31, 2019


Niraparib approved for late-line treatment of women with recurrent ovarian cancer

FDA approved an expanded indication for niraparib, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy.

Patient selection is based on an FDA-approved companion diagnostic.

This represents the first time a PARP inhibitor has been approved for use in patients beyond those with a BRCA-positive mutation as monotherapy in the late-line treatment setting. Now women with late line, HRD-positive disease are eligible to be treated with a PARP inhibitor.

Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other cancer medications have developed bone marrow problems, called myelodysplastic syndrome (MDS), or acute myeloid leukemia (AML), during treatment with niraparib. MDS or AML may lead to death.

The recommended dosage is 300 mg taken once daily, with or without food. Treatment should be continued until disease progression or unacceptable adverse reaction. 

Niraparib may cause serious adverse effects; see the prescribing information for complete details.

Common adverse effects are nausea, fatigue, thrombocytopenia, anemia, vomiting, constipation, abdominal pain, musculoskeletal pain, decreased appetite, neutropenia, insomnia, headache, dyspnea, diarrhea, hypertension, cough, dizziness, hypomagnesemia, urinary tract infection, acute kidney injury, and decreases in white blood cell counts.