CHMP recommends approval of Rubraca in ovarian, fallopian tube and peritoneal cancer.- Clovis Oncology.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Rubraca (rucaparib) from Clovis Oncology. The CHMP adopted a new indication as follows: �Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy�.
Comment: On May 29, 2018, Rubraca became the first PARP inhibitor licensed in the EU as a monotherapy treatment for women with recurrent ovarian cancer. Clovis Oncology announced the submission of a regulatory application to the European Medicines Agency as part of a type II variation seeking to expand the marketing authorization for Rubraca in June 2018.
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