The FDA has Extended Approval of Zejula for Ovarian Cancer Patients With and Without BRCA Mutations

GlaxoSmithKline (GSK) has just announced that Zejula, otherwise known as niraparib, has just been approved for cancer patients beyond those who have a BRCA+ mutation. The patients now included in Zejula’s indication include ovarian cancer, fallopian tube cancer, and primary peritoneal cancer patients. These individuals must have HRD status and have been treated with at least 3 chemotherapy regimens prior to beginning Zejula.

The medication is an oral PARP inhibitor therapy that is taken once each day. It was first approved in March of 2017 and it remains to be the only oral PARP inhibitor that can be taken once daily.

Kathleen Moore was the Lead Investigator of the trial that led to Zejula’s extended indication. She attests to how important this new approval is based on the high rate of recurrence for cancers like ovarian (85% recurrence rate). The ability of this therapy to now be used for patients who don’t have a BRCA mutation is huge.

The Trial That Brought Approval

The trial that led to this therapy’s extended approval was the QUADRA Phase 2 study. It’s aim was to evaluate both the safety and the efficacy of the treatment. This multi-center investigation was the largest trial to date examining PARP inhibitors for women who have already had at least 3 chemotherapy treatments. Participants included those with BRCA+ platinum-sensitive disease, BRCA+ platinum-resistant disease, BRCA+ refractory disease, and HRD+ platinum-sensitive disease. In total, 463 patients participated in this investigation. The starting dose of the treatment was 300mg.

Results were documented for the total participant pool as well as for separate sub groups. The overall objective response rate (ORR) was 24%. The median duration of response was 8.3 months. The subgroup with the greatest ORR was those with BRCA+ platinum-sensitive disease. Subgroup response rates ranged from 19% to 39%.

In addition to these efficacy results, the safety profile of the treatment stayed consistent with previous trials.

Other Studies 

Researchers aren’t stopping with this investigation of Zejula. The therapy is currently in two Phase 3 trials for ovarian cancer- one as a mono therapy and one as a first-line triplet maintenance therapy. It is also in a Phase 2 study for advanced ovarian cancer, being investigated in combination with bevacizumab. Other combination trials include Zejula with pembrolizumab for triple negative breast cancer as well as advanced platinum-resistant ovarian cancer.  

You can read more about these trials here.


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