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Rucaparib for Ovarian Cancer OK'd for Approval in Europe
Source:Zosia Chustecka | Author:profefd1a | Publish time: 2018-03-14 | 297 23次浏览: | Share:
A new option for the treatment of ovarian cancer could soon be available in Europe: the PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor rucaparib ( Rubraca , Clovis).


    A new option for the treatment of ovarian cancer could soon be available in Europe: the PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor rucaparib ( Rubraca , Clovis).
    At its latest meeting the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) recommended a conditional marketing authorization for rucaparib for the treatment of relapsed or progressive ovarian cancer with a BRCA mutation.
    Rucaparib was approved in the United States for this indication in December 2016. 
    The CHMP lists "the benefits" of rucaparib as its antitumor activity, as measured by objective response rate and response duration, as well its safety profile.
    The most common side effects are fatigue, nausea, creatinine elevations, liver enzyme elevations, vomiting, anemia, decreased appetite, dysgeusia, diarrhea, and thrombocytopenia.
    The full indication is "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."
    Extended Indications
    At the same meeting, the CHMP also recommended approval of an extension of indication for cabozantinib ( Cabometyx , Ipsen Pharma).
    Cabozantinib is now indicated for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma. This recommendation was based on the CABOSUN trial, which demonstrated that cabozantinib prolongs progression-free survival in treatment-naive patients with advanced renal cell carcinoma with intermediate or poor risk, says the company. The indication will be updated if approved by the European Commission.
    The drug was already approved for second-line use in kidney cancer, for use after prior vascular endothelial growth factor–targeted therapy.