FDA fast-tracks ovarian cancer drug

The US Food and Drug Administration (FDA) has granted fast track status to stenoparib, an ovarian cancer drug for patients who cannot tolerate platinum-based treatments.

The designation, given to medicines addressing serious medical needs, allows more frequent FDA communication and may enable accelerated approval if criteria are met.

Allarity Therapeutics is developing stenoparib as an option for women with advanced ovarian cancer who have hypersensitivity to platinum drugs such as cisplatin and carboplatin, or whose tumours no longer respond to these therapies.

Ovarian cancer begins in the reproductive organs that produce eggs.

While platinum drugs can shrink tumours and slow their growth, some patients cannot take them due to health complications or allergic reactions to the metal.

Thomas Jensen, chief executive officer of Allarit, said: “We are very pleased that the FDA has granted fast track designation to stenoparib.

“We look forward to engaging closely with the FDA as we advance this program.”

Jensen added that the designation “underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes.”

Stenoparib, first developed by Eisai as E7449 and later called 2X-121, is an oral small molecule that blocks PARP1/2 and tankyrase 1/2 enzymes – proteins involved in cancer cell growth.

Blocking these enzymes is expected to slow tumour progression.

A Phase 1 clinical trial (NCT01618136) showed stenoparib as an add-on treatment was well tolerated and prolonged survival in patients with solid cancers, including five with ovarian cancer.

Phase 1 trials test safety and dosing in small groups.

Allarity is now enrolling patients in a Phase 2 study to determine the best dose – 600mg or 800mg daily as hard gelatin capsules – for women with advanced, recurrent ovarian cancer who cannot take platinum drugs or whose tumours are resistant.

Phase 2 trials test effectiveness in larger patient groups.

Several patients have been receiving treatment since June. The study will measure clinical benefit, progression-free and overall survival, disease control, and response rates over about two years.

The company is using its Drug Response Predictor (DRP) platform to identify patients whose tumour genetics suggest they are likely to respond to stenoparib.

DRP also helps identify biomarkers of response or resistance to treatment.

Fast track designation may also give access to accelerated approval, priority review, or rolling review, potentially bringing the drug to patients more quickly than standard processes.