EMA Restricts Rubraca’s Use Due To Concerns Over Benefit & Safety
Clovis Voluntarily Dropped Drug’s Third-Line Ovarian Cancer Indication In US
Executive Summary
EU doctors are being told not to prescribe Rubraca as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation.
You may also be interested in...
Clovis Withdraws Rubraca’s Original Ovarian Cancer Indication Shows FDA Emphasis On Survival Data
Clovis’ argument that an overall survival advantage seen for the chemotherapy control arm in the ARIEL4 trial is an artifact of the crossover design does not keep third-line and later ovarian cancer use on label; sNDA for first-line maintenance delayed.
Rubraca Ovarian Cancer Maintenance Approval Brings PARP Inhibitor Parity On Broad Indication
US FDA approval of Rubraca's all-comers maintenance therapy for platinum-sensitive ovarian cancer continues model that Zejula and Lynparza used for a broad maintenance indication, with data broken out for germline BRCA mutation-positive patients in the clinical trials section of labeling.
EMA To Update Active Substances Guide To Address Nitrosamine Contamination
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.