Monday October 14, 2019 0 comments
BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS) announced the National Institute for Health and Care Excellence (NICE) has recommended that women with relapsed ovarian cancer in England have access to rucaparib through the Cancer Drugs Fund (CDF).
Rucaparib is available for use within the CDF as an option for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, based on the conditions outlined in the managed access agreement.
"Ovacome welcomes the availability of rucaparib via the CDF as an option for maintenance treatment of platinum-sensitive relapsed high grade serous epithelial ovarian cancer regardless of BRCA status or line of treatment in the relapsed maintenance setting,” said Victoria Clare, CEO of Ovacome, a United Kingdom ovarian cancer charity focused on providing support to anyone affected by ovarian cancer.
“It is vital that the expansion of available maintenance options continues as maintenance treatments extend the time between chemotherapies. Many women with relapsed ovarian cancer know that they are facing a future of managing their disease as a chronic illness.”
“For too long ovarian cancer treatment options beyond chemotherapy or surgery have been limited, and today’s announcement means that women with ovarian cancer have more choice in their treatment than ever before,” said Annwen Jones, CEO of Target Ovarian Cancer, a United Kingdom ovarian cancer charity.
“Target Ovarian Cancer has long campaigned for better treatment for women with ovarian cancer and we are delighted to see this latest development.”
Approximately 6,400 women are diagnosed with ovarian cancer in the UK every year, which equates to roughly 17 every day. Despite advancements in treatment and care, more than 4,000 women still die each year from ovarian cancer in the UK.
Of those treated with surgery and first line chemotherapy, approximately 70% of patients will relapse within the first three years.
“Inclusion of rucaparib in the CDF as an option for maintenance treatment for patients with recurrent ovarian cancer responding to platinum-based therapy regardless of BRCA mutation status or line of treatment in the relapsed maintenance setting represents a much-needed treatment option for women with recurrent ovarian cancer,” said Jonathan Ledermann, professor of medical oncology, UCL Cancer Institute and UCL Hospitals, London, and global principal investigator for non-US sites in the ARIEL3 study.
“I am pleased that the CDF recommendation includes access for the broad patient population evaluated in the ARIEL3 trial which demonstrated rucaparib to be effective in eligible patients, regardless of their BRCA mutation status, providing a clinically-meaningful median progression-free survival of more than one year across the entire population studied by independent radiological review.
“This represents a significant step in the effective management of relapsed ovarian cancer in the NHS in England.”
Clovis said the European Union (EU) conditional marketing authorization is based on data from the pivotal Phase 3 ARIEL3 clinical trial. ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed PFS versus placebo in all patients treated (intention-to-treat, or ITT), population, regardless of BRCA status (median 10.8 months vs 5.4 months).
In addition, it successfully achieved the key secondary endpoint of extending PFS by independent radiological review versus placebo in all patients treated (ITT), regardless of BRCA status (median 13.7 months vs 5.4 months).
The overall safety profile of rucaparib is based on data from 937 patients with ovarian cancer treated with rucaparib monotherapy in clinical trials.5
“We welcome NICE’s recommendation to make rucaparib available through the CDF to all eligible women in England who may potentially benefit from this important therapeutic option,” said Patrick J. Mahaffy, Clovis president and CEO.
“For women with recurrent ovarian cancer, access to new treatments that successfully demonstrate prolonged progression-free survival is essential in the fight against this deadly disease and central to Clovis Oncology’s mission to provide the right drug, to the right patient at the right time.”