Cell Therapeutics has bet the company on an experimental drug for non-Hodgkin’s lymphoma, and today it hit a critical deadline in the nick of time. The Seattle biotech company (NASDAQ: CTIC) said today it turned in its application to the FDA for clearance to start marketing the drug in the U.S., meeting its goal of completing that task before the end of June.
The company is asking the FDA for a faster-than-usual six month review of its application, which the agency sometimes grants to therapies with lifesaving potential. If everything breaks right for the company, it could win approval for pixantrone before the end of the year. The application, like all FDA submissions, contains a huge amount of information on the drug, with 76,000 pages of work.
“This is a major milestone for CTI and is the cornerstone of a turnaround strategy for us in meeting our goals of becoming a profitable operating business,” said Cell Therapeutics CEO James Bianco, in a statement.
Cell Therapeutics has been on a “tight-wire act” this year, Bianco has said, as it has slashed costs, sold assets, and tried to unload debt in order to stay in business long enough to turn the company around.
The drug, a modified form of anthracycline chemotherapy made to be less toxic to the heart, showed promise in a pivotal clinical presented earlier this month at the American Society of Clinical Oncology. A study of 120 patients found that the Cell Therapeutics drug boosted complete remission rates, had a greater ability to shrink tumors, and kept tumors from spreading a longer period of time. The drug, however, hasn’t shown an ability yet to prolong lives—the gold standard for success among cancer drugs. And like all cancer drugs, patients reported some significant side effects, including white blood cell depletion, and a higher incidence of severe cardiac disorders.
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