Introduction

Niraparib (trade name: Zejula) has been approved in Germany since November 2017 for the treatment of a type of advanced ovarian cancer known as “high-grade serous epithelial ovarian cancer,” fallopian tube cancer, or primary peritoneal cancer in women. It is an option for patients who have a late recurrence and who respond to platinum-based chemotherapy (“platinum-sensitive recurrence”).

Ovarian cancer is caused by changes in the genes of cells (mutations). Ovarian cancer often stays undetected for a long time because there are no or only nonspecific symptoms at first. By the time the tumor is detected, it’s often already at an advanced stage. Advanced ovarian cancer is removed surgically. This is usually followed by platinum-based chemotherapy. If the cancer returns (recurrence), doctors distinguish between two types:

  • “Platinum-resistant recurrence” (early recurrence): The cancer returns within 6 months of chemotherapy.
  • “Platinum-sensitive recurrence” (late recurrence): The cancer returns at least 6 months after chemotherapy.

Niraparib can be used in the treatment of a late recurrence. It inhibits the activity of various proteins that make the cancer grow.

Application

Niraparib is available as hard capsules (100 mg). 3 capsules are taken together at around the same time every day. The total daily dose is 300 mg of niraparib. Taking the capsules just before bedtime can help avoid nausea. If the side effects are too severe, the treatment can be stopped for a while or the dose can be adjusted.  If the cancer progresses despite treatment, the treatment is stopped.

Other treatments

If women who have this kind of ovarian cancer (high-grade serous epithelial ovarian cancer) have already had treatment with platinum-based chemotherapy, their options are treatment with the drug olaparib or the “watchful waiting” approach. In this approach, the patient will continue to be cared for and newly occurring symptoms will be investigated. The doctor and patient then decide together what to do next.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether niraparib has any advantages or disadvantages for women with high-grade serous epithelial ovarian cancer who have a late recurrence when compared with olaparib or watchful waiting.

The manufacturer provided data based on an indirect comparison involving 3 studies. The results of this kind of comparison are generally less conclusive than the results of a direct comparison. In this case, one study compared niraparib with a placebo, and two other studies compared olaparib with a placebo. The study showed the following results in these patients:

What are the advantages or disadvantages of niraparib?

Niraparib wasn’t found to have any advantages or disadvantages compared to olaparib.

No difference

There was no difference between the treatments regarding life expectancy.

What remains unanswered?

The manufacturer didn’t provide any data on quality of life, general health, severe side effects and how often the treatment was stopped due to side effects.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of niraparib (Zejula).