FDA Grants Abexinostat Fast Track Status for Follicular Lymphoma

Xynomic Pharmaceutical‘s abexinostat has received Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a fourth-line treatment for follicular lymphoma, the company announced in a press release.

The decision comes after Xynomic applied for the designation at the beginning of August. The FDA grants Fast Track Designation to potential therapies for severe health conditions or those with unmet need and is intended to speed their development and review process by providing more frequent meetings and discussions with the agency.

Although there are treatments available for follicular lymphoma, patients who have this subtype of non-Hodgkin’s lymphoma often need several lines of treatment, and currently, patients whose cancer progresses after three lines of treatment have a poor prognosis.

Abexinostat is an oral inhibitor of histone deacetylase (HDAC) enzymes, which rearrange chromosomes and change which genes are being produced in cells, usually silencing tumor-suppressing genes. By blocking these enzymes, abexinostat aims to increase the number of tumor suppressor genes being produced to try and prevent the growth and division of cancer cells.

A previous Phase 2 trial (EudraCT-2009-013691-47) tested abexinostat in 100 people with different subtypes of relapsed or refractory non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

The 18 participants who had follicular lymphoma responded particularly well to the treatment, showing an overall response rate — the percentage of patients who responded totally or partially to the therapy — of 56%, compared to 28% of all participants.

The duration of response was also higher in participants with follicular lymphoma (16 months), followed by T-cell lymphoma (11.5 months), and diffuse large B-cell lymphoma (1.9 months).

Xynomic is now exploring abexinostat as a fourth-line therapy for follicular lymphoma in the ongoing FORERUNNER Phase 2 trial (NCT03600441). The trial has included 139 patients at clinical centers across the United States, France, and Spain.

The trial’s first outcome measure is responses to the treatment, either complete or partial. Secondary measures include duration of response, time to disease progression or death, quality of life, and overall survival.

Xynomic will also test its leading candidate in two pivotal trials, which will recruit patients with diffuse large B-cell lymphoma and follicular lymphoma at 24 sites across China over the next 12 months.

An ongoing Phase 1/2 trial (NCT03939182) is testing a combination of Imbruvica (ibrutinib) and abexinostat in mantle cell lymphoma and diffuse large B-cell lymphoma. The trial is recruiting participants in New York and New Jersey.

A combination of abexinostat and Novartis‘ Votrient (pazopanib) has also received Fast Track status by the FDA for the treatment of renal cell carcinoma.