The U.K.’s National Institute for Health and Care Excellence, widely known as NICE, is recommending that Clovis Oncology‘s Rubraca (rucaparib) be available as a maintenance therapy for women with recurrent epithelial ovarian, fallopian tube and peritoneal cancer who responded to platinum-based chemotherapy, regardless of their BRCA status or previous lines of treatment.
NICE’s appraisal helps to assure that patients in England will have access, at reduced or no cost, to Rubraca as a maintenance option under the Cancer Drugs Fund (CDF), the National Health Service (NHS) reserve to fund cancer therapies.
An estimated 6,400 women are diagnosed with ovarian cancer in the U.K. every year. Despite advancements in treatment and care, relapse rates continue to be very high. Nearly 70% of patients treated with surgery and first-line chemotherapy experience a return of their cancer within three years.
We welcome “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,” Victoria Clare, CEO of the ovarian cancer charity Ovacome, said in a press release.
“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,” Clare added.
The European Union’s conditional approval is based on data from the pivotal ARIEL3 Phase 3 trial (NCT01968213), where Rubraca maintenance extended the time patients lived without disease progression from 5.4 months to 10.8 months — representing a 64% reduction in the risk of disease progression or death. This survival benefit was seen regardless of whether patients had BRCA mutations.
The overall safety profile of Rubraca is based on data from 937 patients with ovarian cancer treated with the therapy alone in clinical trials.
“Inclusion of rucaparib in the CDF as an option for maintenance treatment for patients with recurrent ovarian cancer responding to platinum-based therapy … represents a much-needed treatment option for women with recurrent ovarian cancer,” said Jonathan Ledermann, MD, professor at UCL Cancer Institute and UCL Hospitals and an ARIEL3 principal investigator.
“This represents a significant step in the effective management of relapsed ovarian cancer in the NHS in England,” he added.
Rubraca was approved as a maintenance treatment for these same patient groups by the U.S. Food and Drug Administration in April 2018.
NICE provisionally rejected Rubraca’s use in ovarian cancer in an August opinion, citing a lack of evidence supporting a clear benefit in patient survival relative to its cost.
“NICE felt there wasn’t enough evidence to be confident about the drug’s long-term benefits, and that the benefit it gave wasn’t enough to justify its cost,” Rose Gray, policy manager at Cancer Research UK, said in a press release at that time.
But the agency announced a review of its decision in September.
“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 Oncology’s 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.”
Added Annwen Jones, CEO of Target Ovarian Cancer, another U.K. charity: “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.”