EMA Restricts Rubraca’s Use Due To Concerns Over Benefit & Safety
Clovis Voluntarily Dropped Drug’s Third-Line Ovarian Cancer Indication In US
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.
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Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.
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.
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.