Allarity Therapeutics Receives FDA Fast Track Designation for Stenoparib in Advanced Ovarian Cancer Treatment

Allarity Therapeutics has been granted FDA Fast Track designation for stenoparib, an investigational drug for advanced ovarian cancer. The designation enables expedited development and review processes, potentially leading to accelerated approval and priority review. The company is currently enrolling patients in a Phase 2 clinical trial to evaluate stenoparib in platinum-resistant ovarian cancer. Stenoparib is a dual PARP and WNT pathway inhibitor that aims to overcome resistance challenges faced by standard PARP inhibitors.

Allarity Therapeutics has received significant regulatory support from the U.S. Food and Drug Administration (FDA) by securing Fast Track designation for stenoparib, an investigational drug aimed at treating advanced ovarian cancer. This designation is designed to expedite the development and review process, potentially leading to accelerated approval and priority review [1].

Stenoparib is a dual PARP and WNT pathway inhibitor, offering a unique therapeutic mechanism compared to existing PARP inhibitors. The drug targets PARP1/2 and tankyrase 1/2, pathways linked to cancer development. By inhibiting these pathways, stenoparib aims to overcome resistance challenges faced by standard PARP inhibitors [2].

The FDA's Fast Track designation for stenoparib reflects the significant unmet medical need in the treatment of advanced ovarian cancer. This designation allows for more frequent interactions with the FDA, enhancing the likelihood of accelerated approval if the clinical data meet the necessary criteria. The ongoing Phase 2 clinical trial is enrolling patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer, targeting a particularly difficult-to-treat patient population [1].

The trial, which began enrollment in June 2025, builds on previous Phase 2 data that demonstrated durable clinical benefit. Some participants have remained on treatment for over 22 months, suggesting the potential for sustained disease control. The trial also incorporates Allarity’s DRP companion diagnostic, which uses messenger RNA expression profiles from patient tumor biopsies to predict response to therapy and guide treatment decisions [2].

The integration of the DRP companion diagnostic represents a precision medicine approach that could potentially identify patients most likely to respond to treatment, increasing the probability of clinical success and eventual regulatory approval. This precision approach aims to enhance the therapeutic benefit rate by screening patients before treatment and only treating those with a sufficiently high, drug-specific DRP score [2].

Allarity Therapeutics, a Phase 2 clinical-stage pharmaceutical company, is dedicated to developing stenoparib and its DRP companion diagnostic. The company recently began patient enrollment under the new Phase 2 clinical trial protocol, with the first patient enrolled in early June 2025 [2].

The FDA's Fast Track designation for stenoparib is a significant regulatory milestone for Allarity Therapeutics, acknowledging the serious nature of advanced ovarian cancer and the potential of stenoparib to address unmet needs in this patient population. This designation offers substantial regulatory advantages, including more frequent FDA interactions, potential eligibility for accelerated approval, priority review, and rolling review processes. These benefits can meaningfully compress development timelines, potentially bringing stenoparib to market faster if clinical data support approval [2].

References:
[1] https://www.curetoday.com/view/fda-gives-fast-track-designation-to-stenoparib-in-advanced-ovarian-cancer
[2] https://www.stocktitan.net/news/ALLR/allarity-therapeutics-granted-fda-fast-track-designation-for-rke0y4wbla6w.html