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FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access

Cell Therapeutics (CTI) has decided to pursue an expanded access program for its non-Hodgkin’s lymphoma drug Pixuvri, while conducting an additional trial needed for approval. CTI plans to request a meeting with the FDA to discuss the expanded access program and design of the follow-on study. The company said it received a complete response letter from the agency citing concerns with trial data raised at a meeting of the Oncologic Drugs Advisory Committee last month.
Drug Industry Daily

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