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
