The US Food and Drug Administration (FDA) has reprimanded a pharmaceutical company over its promotion of an investigational drug at an exhibition stand at the American Society of Clinical Oncology (ASCO) annual meeting earlier this year.
The company, Celator, had displayed an exhibition panel about its investigational drug CPX-351 (a combination of cytarabine and daunorubicin) liosome injection (Vyxeos) in the treatment of acute myeloid leukemia (AML).
In a letter to the company, the FDA said that the panel suggested, in a promotional context, that the drug was safe and effective for this indication; the letter also pointed out that the drug is not approved in the United States.
The panel had highlighted results from a phase 3 clinical trial showing that the product (a 5:2 ratio of cytarabine:daunorubicin) had shown improved survival when compared the standard 7:3 ratio of these chemotherapy drugs in high-risk patients with newly diagnosed AML. Results from this trial were presented at the ASCO annual meeting and were hailed as heralding a new standard of care during a "Highlights of the Day" session, as reported at the time by Medscape Medical News. However, all that took place at the scientific sessions of the meeting.
At the same time, the results were displayed in the exhibition hall at the company's stand. The panel displaying these results did not say that CPX-351 was an investigational product, and the panel was displayed in the main exhibition hall alongside promotion for approved products, the FDA noted in its letter.
This is a violation of the Federal Food Drug & Cosmetic Act and from a public health point of view is "concerning" because this was promotion of an unapproved product.
Celator has since been acquired by Jazz Pharmaceuticals (in July 2016): However, at the time of the ASCO annual meeting in early June 2016, the company was still trading as Celator.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου