Women in England and Wales with recurrent, platinum-sensitive ovarian cancer can now access Zejula (niraparib) through the Cancer Drugs Fund (CDF) after a recommendation by the U.K.’s National Institute for Health and Care Excellence (NICE).
Zejula, developed by Tesaro, is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance of ovarian cancer patients who are in a complete or partial response to platinum-based chemotherapy.
Because this is the first PARP inhibitor shown to be effective in patients both with and without a BRCA mutation, NICE has recommended Zejula for women (regardless of BRCA mutation) who have received two lines of chemotherapy.
“At Tesaro, we continue to globalize our mission and bring transformative therapies to patients. We are pleased that NICE will now provide more women with recurrent ovarian cancer in England and Wales access to Zejula through the CDF,” Orlando Oliveira, senior vice president and general manager of Tesaro, said in a press release.
“Through close partnership with both NICE and NHS, Tesaro can now offer Zejula as an option for second-line maintenance treatment, regardless of a patient’s BRCA status,” he added.
The U.K.’s CDF is a source of funding for cancer drugs, providing patients earlier access to promising new treatments while England’s National Health Service (NHS) and NICE study additionally requested data before making a final decision on reimbursement for a new treatment or indication.
“Recurrent ovarian cancer is an aggressive form of cancer where a key goal of treatment is to keep women in remission and off chemotherapy for as long as possible — allowing them the best chance for a good quality of life,” said Jonathan Ledermann, professor of medical oncology at University College London Cancer Institute.
“Zejula offers the chance to delay this cancer from returning or progressing for months, and possibly years in some cases,” he said. “It is a significant step forward. Crucially, this decision opens the door for many women who, until now, have not had the option of maintenance treatment with a PARP inhibitor.”
After its approval by the European Commission, Zejula became the first PARP inhibitor in Europe that does not require women to have a BRCA mutation or other biomarker testing.
The approval was based on data from the ENGOT-OV16/NOVA Phase 3 trial (NCT01847274), which enrolled 553 recurrent ovarian cancer patients who had achieved a partial or complete response to their most recent platinum-based chemotherapy. About two-thirds of participants didn’t have inherited BRCA mutations.
The study tested whether Zejula was better than a placebo at delaying disease worsening in these patients. While progression-free survival was the trial’s main goal, researchers also assessed overall survival, patient-reported outcomes, and chemotherapy-free interval as secondary measures.
Results showed that Zejula extended the time to disease worsening or death from 5.5 months to 21 months, reducing the risk of disease progression or death by 74 percent. The benefits were seen across regardless of BRCA mutations, researchers found.
Treatment with Zejula reduced the risk of disease progression or death by 73 percent in patients with inherited BRCA mutations and by 55 percent in patients without the mutations.
The benefit was similar for patients who had achieved a partial or complete response to platinum-based chemotherapy before entering the trial.
Zejula was approved in the U.S. in March 2017 for the same indication.
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