Seattle based Cell Therapeutics (CTI) has withdrawn its application for approval of pixurvi (pixantrone) from the US Food & Drug Administration due to what the company is calling 'unresolved communications' with the regulatory agency.
The FDA's oncology advisory committee was planning on reviewing pixantrone next week and issuing its recommendation to the FDA, which itself had planned to announce by April 24 whether or not the third-line therapy for relapsed or refractory non-Hodgkin's lymphoma would be approved.
CTI's decision to withdraw the drug from consideration all but indicates which way the committee was leaning, i.e. towards rejection, which would have been in line with how the committee and agency have felt about pixantrone since the company submitted its disastrous phase III data last year.
CTI says it will resubmit the drug in the near future. Either way, with this withdrawal CTI remains a bizarre biopharmaceutical company, one that has managed to be in business for two decades without ever having developed a drug for approval or, arguably, made much money at all, although they have spent money in the hundreds of millions. In fact, unlike the company's many shareholders, CTI's CEO, James Bianco, was awarded handsomely last year, along with other company principles.
Source: The Street
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