FDA Gives Fast Track Designation to Stenoparib in Advanced Ovarian Cancer

The U.S. Food and Drug Administration (FDA) has granted fast track designation to stenoparib, an investigational therapy for patients with advanced ovarian cancer, according to a release from Allarity Therapeutics.

This designation is meant to speed the development and review of new treatments that target serious conditions and fill an unmet medical need, the release states. It also provides opportunities for more frequent FDA interactions and can offer eligibility for accelerated approval, priority review, or rolling submission if requirements are met.

“We are very pleased that the FDA has granted Fast Track designation to stenoparib,” said Thomas Jensen, CEO of Allarity Therapeutics. “This recognition underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes.”

Phase 2 Clinical Trial of Stenoparib Now Enrolling Patients

Allarity opened enrollment of a new phase 2 trial studying the treatment in patients with advanced, recurrent ovarian cancer who are either platinum-resistant or platinum-ineligible. The first patient entered the trial in June 2025, and several patients have already started therapy.

The study builds on prior phase 2 findings, which showed clinical benefit. Some participants have remained on treatment for more than 22 months, suggesting the potential for durable responses. The trial also incorporates Allarity’s DRP companion diagnostic, which is designed to help identify patients most likely to respond to therapy and guide treatment decisions.

How Stenoparib Targets Specific Pathways in Ovarian Cancer

Stenoparib is an oral small-molecule drug that works as a dual inhibitor of PARP1/2 and tankyrase 1/2. Both pathways are linked to cancer development. By targeting these pathways, stenoparib offers a unique therapeutic mechanism compared with existing PARP inhibitors, the news release states.

Moreover, the drug was originally developed by Eisai Co. Ltd. and was previously known as E7449 and 2X-121. Allarity holds exclusive global rights to further develop and commercialize the therapy.

DRP Companion Diagnostic Helps Match Patients to Treatment

The DRP technology uses messenger RNA expression profiles from patient tumor biopsies to generate a gene signature that predicts response to a drug. Patients with a higher DRP score are thought to have a greater likelihood of benefiting from treatment. This platform has been studied across multiple clinical trials and has demonstrated the ability to predict outcomes.

“By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced,” the news release explains. “The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies.”

For stenoparib, DRP may allow clinicians to better select patients who will respond, potentially improving overall treatment success.

Understanding Ovarian Cancer Symptoms, Risk, and Progression

Ovarian cancer begins when abnormal cells in the ovary grow and divide uncontrollably, according to information from the Cancer Research UK website. These cells may spread into nearby tissues or travel to other areas of the body. The ovaries are part of the reproductive system, which includes the vulva, vagina, uterus, cervix, fallopian tubes, and ovaries. Each ovary produces eggs during the reproductive years.

Anyone born with ovaries and fallopian tubes may develop ovarian cancer, including women, transgender men, and non-binary individuals, the website continues. Risk increases with age, peaking between ages 75 and 79. Although the exact cause is unknown, several factors can influence an individual’s likelihood of developing the disease.

References

1. “Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer,” by Allarity Therapeutics, Inc. News release; Aug. 26, 2025.
2. “What is Ovarian Cancer?,” by Cancer Research UK. https://www.cancerresearchuk.org/about-cancer/ovarian-cancer/what-is-ovarian-cancer

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