Zejula® Approved for Recurrent Ovarian, Fallopian Tube, and Peritoneal Cancer

The United States Food and Drug Administration (FDA) has approved the agent Zejula (niraparib) for the treatment of recurrent ovarian, fallopian tube, and peritoneal cancers. The indication for this approval includes its use for maintenance therapy for these types of cancers that have achieved a partial or complete disappearance following platinum-based chemotherapy. Maintenance therapy is intended to delay the growth of cancer cells following prior therapy.

 

The National Cancer Institute (NCI) estimates that over 22,000 women will be diagnosed with ovarian, fallopian tube, or peritoneal cancers in 2017, and more than 14,000 will succumb to these diseases. The ovaries are located in the pelvis, and are responsible for storing and releasing female eggs, as well as producing female hormones. The fallopian tubes carry the egg from the ovaries to the uterus, and the peritoneum is a lining of the abdominal wall.

 

Zejula creates anti-cancer effects by blocking an enzyme called ADP-ribose polymerase (PARP). PARP helps to repair damaged DNA within cells; if it is blocked, it is unable to repair damaged DNA within cancer cells, which can result in their death. Zejula is referred to as a PARP inhibitor.

 

The trial that prompted FDA approval of Zejula included 553 patients with recurrent ovarian, fallopian tube or peritoneal cancers of epithelial origin (meaning the cancer started in the epithelial cells which line the organs or structures). Patients had received at least 2 prior therapies, and had experienced a partial or complete disappearance of their cancer following their last treatment which included a platinum-based chemotherapy. One group of patients was treated with Zejua, and one group received a placebo (inactive substitute) as maintenance therapy. Patients were also tested for the genetic mutation referred to as BRCA which is a mutation associated with an increased risk of developing ovarian cancer.

 

  • The median duration of time for cancer to progress for patients with the BRCA mutation was 21 months for those treated with Zejula, compared with only 5.5 months for those who received placebo.
  • The median duration of time for cancer to progression for patients without the BRCA mutation was 9.3 months for those treated with Zejula, compared with only 3.9 months for those who received placebo.
  • Common side effects associated with Zejula were low levels of blood cells, heart palpitations, and gastrointestinal symptoms.

 

Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence stated that “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation.”

 

Patients with recurrent ovarian, fallopian tube, or peritoneal cancers may wish to speak with their physician regarding their individual risks and benefits of treatment with Zejula.

 

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