The Food and Drug Administration on Monday announced that there was insufficient clinical evidence involving a proposed Cell Therapeutics, Inc. drug that would treat non-Hodgkin's lymphoma, and revealed that the medicine significantly posed side effects, according to documents released.
The Seattle-based biotechnology company has initiated an approval request to sell pixantrone under the brand name Pixuvri for treating non-Hodgkin's lymphoma that has stopped responding to other treatments.
The agency posted the main clinical study for the drug, pixantrone, was shut down early because doctors faced a difficult time recruiting patients into the trial.
Pixantrone encounters a review initiated by the outside panel of medical experts on Wednesday who serve on the FDA's oncologic drugs advisory committee.
Study researchers had planned to enroll 320 patients in the study while one of the main studies of the drug included 140 patients.
The target to seek whether patients responded to the drug for at least four months claimed that 25.7% of patients in the pixantrone group achieved a so-called overall response compared with 8.6% of patients who didn't receive the drug.
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