Gloucester Pharmaceuticals, Inc. Receives Special Protocol Assessment For Pivotal Phase II Trial Of Romidepsin In Patients With Peripheral T-Cell Lymphoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Gloucester Pharmaceuticals, Inc., an oncology focused specialty pharmaceutical company, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the FDA’s Special Protocol Assessment (SPA) process for the design of its planned 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.
MORE ON THIS TOPIC