CTI will appeal FDA pixantrone ruling

Cell Therapeutics doesn't want to take 'no' for an answer. The developer, which recieved a harsh FDA rejection of pixantrone for relapsed/refractory aggressive non-Hodgkin's lymphoma, said today that it plans to appeal the FDA's decision.

"After discussions with a number of leading U.S. and international lymphoma experts and leading biostatisticians, all of whom have reviewed the (pixantrone) protocol, statistical plan and trial results, we felt encouraged to appeal the initial decision and have our data reviewed in the context of a trial that achieved statistically and clinically meaningful primary and secondary endpoints in this end stage patient population for whom there are no approved or effective agents," said company CMS Jack Singer in a statement.

CTI is preparing to file an appeal under the FDA's Formal Dispute Resolution process, which it expects to do in Q4 2010. The company also plans to begin another pixantrone clinical study in the U.S.--a hurdle the FDA said would be necessary to achieve approval of the drug.

- here's the Cell Therapeutics statement
- take a look at the Puget Sound Business Journal report

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