Generic Name: niraparib
Drug Class: Targeted Therapy Medications
Company: Tesaro
Approval Status: Experimental
Generic Version Available: No
Drug Indication
Zejula is a PARP inhibitor approved for the treatment of advanced ovarian, fallopian
tube or primary peritoneal cancer in people with harmful BRCA mutations or genomic instability, as well as for maintenance therapy for people with recurrent or advanced cancer that is responding to platinum chemotherapy.
General Info
Zejula blocks poly ADP-ribose polymerase (PARP) proteins, which play a role in DNA damage repair. Inhibiting PARP leads to more DNA breaks in cancer cells, which halts cell division. People with harmful BRCA mutations, or a set of related genetic alterations known as homologous recombination deficiency, do not make proteins that repair this kind of DNA damage, so BRCA-related cancers are especially susceptible to these drugs.
The QUADRA trial showed that Zejula shrank tumors in 24% of advanced ovarian cancer patients with harmful BRCA mutations or genomic instability who had been treated with three or more chemotherapy regimens. The NOVA trial showed that Zejula as maintenance therapy improved progression-free survival in women with recurrent ovarian, fallopian tube or primary peritoneal cancer who were responding to platinum-based chemotherapy. Improvement was greater in those with BRCA mutations. The PRIMA trial showed that Zejula maintenance therapy delayed disease progression in people with advanced ovarian cancer who has a complete or partial response platinum chemotherapy. Zejula was first approved in 2017.
Dosage
Dosing Info: Zejula is taken as a capsule twice daily with or without food.
Side Effects
Common side effects include nausea and vomiting, constipation, abdominal pain, mouth sores, fatigue, muscle and joint pain, headache, dizziness, unusual taste sensations and skin rash. Zejula can cause depletion of red blood cells (anemia), white blood cells (neutropenia) and platelets (thrombocytopenia), which can lead to infections and easy bleeding. Potentially serious side effects include high blood pressure and increased risk of leukemia or myelodysplastic syndrome. Zejula should not be used during pregnancy.
For More Info: https://www.zejula.com
Patient Assistance Program Info: https://www.zejula.com/en/access-support
Last Reviewed: April 30, 2020
