First PARP inhibitor licensed for ovarian treatment indication in the EU
Following a favorable opinion from the European Medicines Agency advisory committee in March this year, the European Commission (EC) has now approved the first poly ADP-ribose polymerase (PARP) inhibitor licensed for ovarian cancer in the European Union.
US biotech firm Clovis Oncology (Nasdaq: CLVS) yesterday announced that the EC has authorized Rubraca (rucaparib) as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
Certain confirmatory post-marketing commitments are required as part of this conditional authorization, noted the company, whose shares were virtually unchanged by close on Tuesday, but were up 1.2% at $49.33 in early trading this morning.
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