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Lymphoma
Gloucester wins SPA for phase II trial of romidepsin in PTCL
February 27th, 2007
Gloucester Pharmaceuticals, Inc., an oncology-focused specialty-pharmaceutical company, announced that it has reached an agreement with the U.S. Food & 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. A special protocol assessment 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....
Source: Cancer Weekly (2007-02-27)
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