Drug Claims at ASCO Meeting Lead to Enforcement Promotion Letter for Celator

September 14, 2016

Celator Pharmaceuticals has received a drug enforcement promotion letter as a result of a drug it showcased during the annual meeting of the American Society of Clinical Oncology (ASCO).

During the meeting, a panel discussed Celator’s product CPX-351 in treating cancer in general and patients with high-risk acute myeloid leukemia (AML). The product was touted as easily administered by users themselves. According to the FDA, the use of the drug as described requires the supervision of a physician.

In addition, Celator makes claims about the drug, including that “In vitro research has shown that a 5:1 ratio of cytarabine-daunorubicin delivers optimal anti-cancer activity.” None of the claims listed in the letter have been supported through human trials.

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