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FDA committee votes 9-0 against Cell Therapeutic's pixantrone
The hopes that Cell Therapeutics has for its drug pixantrone gaining FDA approval took a massive hit today when the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 9-0 against granting the company marketing approval for the medication.
Members of the committee claimed that the single study supporting the drug was neither "well designed nor well executed" and noted that its efficacy-- just 20% of the cohort achieved a major response to the drug -- was below acceptable standards.
The company's shares fell by almost 50% when the news broke. The FDA will make a final decision in late April, but most expect the agency to follow the recommendation of the ODAC.