Clovis Oncology has announced it will withdraw its FDA approval application for Rubraca, its third-line BRCA-mutated ovarian cancer drug. The company is also withdrawing its application for approval by the European Medicines Agency. The move comes after overall survival data found that a subset of patients had a higher risk of death on the drug, despite having lower rates of progression.
According to John Carroll, “Clovis discounted any big impact, noting that they only get a “small portion” of their revenue from third-line use, though analysts might argue that the company has performed poorly overall as an also-ran PARP behind AstraZeneca and GSK. The company also noted that there could be some spillover effects in its overall marketing campaign.”
To learn more, click here.
(Source: Endpoints News, June 17th, 2022)