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news.Gloucester Pharmaceuticals has reached an agreement with the FDA under a special protocol assessment for the design of its trial of romidepsin in patients with peripheral T-cell lymphoma.
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This trial will enroll peripheral T-cell lymphoma (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 trials.
“PTCL is a challenging disease for which there are no currently approved drugs,” commented Jean Nichols, executive vice president at Gloucester Pharmaceuticals.
“We continue to see encouraging data for romidepsin in T-cell malignancies, including recently presented data from an NCI-sponsored study in PTCL that included a significant overall response rate and duration of response in previously treated patients. We expect to initiate our pivotal study later this quarter.”
An interim analysis of the NCI's phase II study of romidepsin as a treatment for PTCL showed overall response rate of 30% was reported, with 8% having complete and 22% with partial responses.