Rubraca Reimbursement Approved in Italy for Women With Relapsed Platinum-sensitive Ovarian Cancer

Rubraca Reimbursement Approved in Italy for Women With Relapsed Platinum-sensitive Ovarian Cancer
The Italian Medicines Agency (AIFA) has approved Clovis Oncology’s Rubraca (rucaparib) for reimbursement in Italy as a maintenance therapy for women with relapsed ovarian cancer who responded to platinum-based chemotherapy, regardless of their BRCA status. This follows Rubraca’s approval for that indication by the European Commission early this year. “The reimbursement of Rubraca in Italy is an important step in the ovarian cancer treatment pathway, as it has shown to be effective across a broad population of women with relapsed ovarian cancer,” Patrick J. Mahaffy, Clovis Oncology’s president and CEO, said in a press release. “We are working to make Rubraca available to as many eligible patients as possible across Europe, and we look forward to additional country launches in the coming months,” Mahaffy added. Ovarian cancer is the eighth most commonly occurring cancer in women worldwide and is associated with a five-year survival rate of less than 50%. It is estimated that 5,000 women are diagnosed with ovarian cancer in Italy every year, and that their five-year survival rate is 39%, falling to 31% at 10 years. Rubraca is a PARP inhibitor that works by blocking the activity of the PARP enzyme — a DNA damage sensor. That leads to the accumulation of DNA damage, and ultimately the death of cancer cells. PARP inhibitors are particularly effective in cancer cells with defects in other DNA repair mechanisms — such as those with mutations in the BRCA1 and BRCA2 genes — due to their reliance on PARP to survive and proliferate. Mutations in the BRCA1 and BRCA2 genes are estimated to occur in 25% of ovarian cancer patients. The presence of BRCA mutations has been associated with better treatment responses, likely due to a larger n
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