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Home » Clovis Abandons Previous FDA Approval of Rubraca Following Study Data
Clovis Abandons Previous FDA Approval of Rubraca Following Study Data
Clovis Oncology has requested a withdrawal of FDA approval of Rubraca (rucaparib) for treating patients with BRCA-mutated ovarian cancer after two or more chemotherapies.
The withdrawal was based on disappointing data from a study that enrolled 564 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who were in response to platinum-based chemotherapy.
The results were not statistically significant in participants taking Rubraca compared with those who were given a placebo.
The company has also requested a withdrawal of the indication in Europe.
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