GLOUCESTER RECEIVES SPA FOR T-CELL LYMPHOMA TRIAL

Gloucester Pharmaceuticals has reached an agreement with the FDA under the special protocol assessment (SPA) process for the design of its planned Phase II pivotal trial of romidepsin in patients with peripheral T-cell lymphoma (PTCL). This single-arm trial will enroll PTCL patients who have progressed or become refractory following systemic therapy.

An SPA is a request for feedback from the FDA that allows a company to receive official evaluation and guidance on the design and size of pivotal clinical trial protocols, according to Gloucester. A company can request this formal assessment for a pivotal trial that is intended to form the primary basis of an efficacy claim in a new drug application.

Romidepsin is a novel agent in a new class of anticancer drugs known as histone deacetylase inhibitors. The company is also conducting a pivotal Phase II study of romidepsin for patients with cutaneous T-cell lymphoma (CTCL). Romidepsin has received fast-track status and orphan drug designation from the FDA for evaluation for CTCL and PTCL. These trials are being conducted by the company and the National Cancer Institute under a cooperative research and development agreement.