欧州医薬品庁(EMA)が、PARP阻害薬rucaparib(RUBRACA®)について、再発卵巣がんへの維持療法薬としての適応拡大申請を受理【Clovis Oncology】

CLOVIS ONCOLOGY RECEIVES EMA VALIDATION FOR ITS APPLICATION FOR A NEW INDICATION FOR RUBRACA® (RUCAPARIB) AS MAINTENANCE TREATMENT FOR WOMEN WITH RECURRENT OVARIAN CANCER


Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Medicines Agency (EMA) has validated the application for a Type II variation to the marketing authorization for Rubraca® (rucaparib) to include maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum based chemotherapy. This validation confirms the submission is complete and begins the EMA’s centralized review process.

 

 

 

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