FDA OKs Cell Therapeutics' manufacturing plant

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The FDA has approved Cell Therapeutics' facility to manufacture Pixuvri (pixantrone), an experimental cancer drug that is currently under review. The NerPharMa facility, which belongs to Nerviano Medical Sciences, is based in Nerviano, Italy. "FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," says Craig Philips, president of CTIC.

Cell Therapeutics' closely-watched pixantrone is a potential treatment for relapsed/refractory aggressive non-Hodgkin's lymphoma. The FDA's decision will be a make-or-break moment for the struggling developer, with many analysts expecting the FDA to rule against the drug. FDA staffers have raised questions about the treatment, expressing concerns about both the drug's effectiveness, as well as its safety profile. An ODAC meeting is scheduled for March 22, and the FDA is expected to make a final decision on approval of the NDA for pixantrone by April 23.

- see CTIC's release
- here's the Reuters Article