EC approves pharmaand’s Rubraca as advanced ovarian cancer maintenance treatment
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来源: PMLiVE
The European Commission (EC) has approved pharmaand’s (pharma&) Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer in patients who have responded to first-line platinum-based chemotherapy.
The PARP inhibitor, which has been authorised for use in all advanced ovarian cancer patients regardless of their BRCA mutation status, was previously approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancerplatinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancerplatinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.
The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage ATHENAMONO trial.
Results showed that, as a first-line maintenance treatment, Rubraca significantly improved investigator- assessed progression-free survival compared with placebo in advanced ovarian cancer patients, regardless of BRCA mutation status.
The safety profile observed in the ATHENAMONO trial was also consistent with both the current US and European labels for Rubraca, the company said.
An estimated 66,000 people in Europe are diagnosed with ovarian cancer each year and, despite recent advances in newly diagnosed ovarian cancer, advanced cases of the disease are still considered incurable for the majority of patients.
Frank Rotmann, founder and managing director of pharma&, said the approval "will help to ensure that healthcare providers and eligible patients, regardless of their BRCA mutation status, have access to and may benefit from [Rubraca] earlier in their treatment journey".
Elmar Zagler, also founder and managing director of pharma&, added that the company looks forward to “broadening access to the potential benefits of [Rubraca] to a wider group of eligible patients living with advanced ovarian cancer in Europe”.
The approval comes just months after pharma& acquired Rubraca from Clovis Oncology as part of an auction associated with Clovis' bankruptcy proceedings.
pharma& paid $70m upfront for the rights to the drug, according to a regulatory filing at the time, which also outlined that the company could pay another $65m if certain regulatory and sales milestones are met.
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