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 regulatory milestone, the sponsor engaged Catalyst Oncology to design and launch a global study under intense time and recruitment pressures.

Catalyst rapidly assembled an experienced team to lead global project management, regulatory strategy, 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 enrollment. Catalyst also recalibrated timelines and expanded networks to maintain compliance. Within 10 months, the trial was initiated, enabling a timely NDA submission and accelerated approval. The confirmatory study continues as a post-marketing requirement, supporting patient access to the first therapy specifically approved for this rare ovarian cancer.