Tesaro Inc has announced the National Institute for Health and Care Excellence (NICE) will make Zejula®(niraparib), the first PARP inhibitor shown to be effective in patients with a BRCA mutation as well as those without a BRCA mutation, available to women in England and Wales with recurrent platinum-sensitive ovarian cancer via the Cancer Drugs Fund (CDF).1
NICE has recommended Zejula via the CDF for women with a BRCA mutation who have received two lines of chemotherapy and in women without a BRCA mutation who have received two or more lines of chemotherapy.
“At Tesaro, we continue to globalise 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,” said Orlando Oliveira, Senior Vice President and General Manager, Tesaro International.
“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.”
The CDF is a source of funding for cancer drugs in England, providing patients access to promising new oncology treatments while NHS England and NICE analyse any additionally requested data to inform a final reimbursement decision on a new treatment or indication.
Overall survival data for Zejula are not yet available, and as a result NICE has recommended Zejula for use within the CDF while further data are collected.2 Interim funding is provided via the CDF, giving patients access to the treatment through a managed access arrangement.
“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 the 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. 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.”
- National Institute for Health and Care Excellence Final appraisal determination. Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer
- Cancer Research UK, Ovarian cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer. Accessed May 2018