NIRAPARIB

Niraparib is an oral poly-adenosine diphosphate-ribose polymerase (PARP) inhibitor developed to treat ovarian and related cancers by exploiting DNA repair weaknesses in tumour cells. Research into PARP inhibition began in the late 1990s, with Niraparib being designed to selectively block PARP enzymes, leading to cancer cell death due to accumulated DNA damage. The U.S. FDA first approved Niraparib in March 2017 as a maintenance treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who achieved a complete or partial response to platinum-based chemotherapy. In April 2020, it received expanded FDA approval for first-line maintenance treatment of advanced ovarian cancer regardless of BRCA mutation status. It is approved in the European Union, India, and other regions for similar uses.

Niraparib is used in the treatment of: Maintenance therapy for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to platinum-based chemotherapy. Maintenance treatment of recurrent ovarian cancer in patients (with or without BRCA mutation) who achieved a complete or partial response after platinum-based chemotherapy. Investigational and off-label studies are also exploring its use in endometrial cancer, prostate cancer, and breast cancer with homologous recombination deficiency (HRD).

Common (mild to moderate): Nausea, vomiting Fatigue Constipation or loss of appetite Insomnia Headache or dizziness Stomach pain Serious (seek urgent medical attention): Severe anaemia (pale skin, extreme tiredness, shortness of breath). Thrombocytopenia (unexplained bruising, bleeding gums, nosebleeds). Hypertension (severe headache, chest pain, blurred vision). Bone marrow suppression (frequent or severe infections). Rare but serious: Myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) Allergic reactions (swelling, rash, breathing difficulty)

Bone marrow suppression : Regular monitoring of blood counts is essential. High blood pressure : Can worsen or develop during treatment. Heart effects: May cause palpitations or cardiovascular strain in some patients. Pregnancy/Breastfeeding: May harm the unborn or nursing baby; not recommended. Secondary cancers: Rare cases of MDS/AML have been reported.

Blood pressure monitoring: Required regularly during therapy. Routine blood tests: For blood counts, kidney, and liver function. Avoid pregnancy: Effective contraception during and after treatment. Inform your doctor: If you have a history of heart disease, blood disorders, or uncontrolled hypertension. Alcohol: Limit intake, as it may worsen dizziness, nausea, or liver effects. Drug interactions: Always share your complete medication list.

Mansoor Raza Mirza et al., “Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer,” The New England Journal of Medicine, [Dec 2016], showing significant improvement in progression-free survival with niraparib https://www.nejm.org/doi/full/10.1056/NEJMoa1611310 Bradley J. Monk et al., “Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer,” The New England Journal of Medicine, [Jun 2019], PRIMA trial establishing niraparib as frontline maintenance therapy https://www.nejm.org/doi/full/10.1056/NEJMoa1910962 U.S. Food and Drug Administration (FDA), “FDA approves niraparib for first-line maintenance of advanced ovarian cancer,” [April 2020] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-first-line-maintenance-advanced-ovarian-cancer European Medicines Agency (EMA), “Zejula (niraparib): EPAR – Product Information,” [Accessed Sept 2025], regulatory details for EU approval https://www.ema.europa.eu/en/medicines/human/EPAR/zejula