Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought accelerated FDA approval, requiring a confirmatory phase III trial to be underway. To meet this milestone, the sponsor engaged Catalyst Oncology to launch and manage a global study under intense time and recruitment pressures.

Catalyst quickly assembled an experienced team to lead global project management, regulatory, site activation, and clinical monitoring, while coordinating with the sponsor’s partners for data and safety oversight. A data-driven site selection model and proactive patient engagement initiatives supported rapid startup and enrollment. Timelines were accelerated mid-study to meet updated regulatory guidance and ensure a timely NDA submission. Catalyst delivered in under 10 months, enabling FDA accelerated approval. The confirmatory study continues—as a post-marketing requirement—enabling global patient access to the first therapy specifically approved for this rare form of ovarian cancer.