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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.

June 22, 2022

https://www.fdanews.com/

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