Jazz subsidiary warned over misbranding of cancer drug
- A promotional poster touting the benefits of an experimental cancer drug caught the attention of the Office of Prescription Drug Promotion (OPDP) at the Food and Drug Administration, leading the regulator to warn the drug's manufacturer, Celator Pharmaceuticals, of misbranding in an untitled letter sent last month.
- Celator, which was bought by Jazz Pharmaceuticals in July, improperly advertised its investigational new drug CPX-351 on a large panel at the widely attended annual meeting of the American Society of Clinical Oncology in June.
- Even though CPX-351 hasn't been approved by the FDA, Celator displayed the poster using the drug's proprietary name, Vyxeos, without reference to it being still under investigation. Celator's poster also suggested the drug improved survival compared to chemotherapy in patients with risk acute myeloid leukemia — a claim the FDA hasn't approved.
The untitled letter sent to Celator was only the third such warning sent by the OPDP this year. OPDP regulators had previously flagged a co-pay assistance voucher distributed by Shionogi and a YouTube video uploaded by Pfizer's Hospira unit.
The OPDP asked Celator, now Jazz, to "immediately cease violating the FD&C [Food, Drug, and Cosmetic] Act" and explain in writing how it intend to discontinue use of materials similar to the ASCO poster.
Aside from referring to CPX-351 as Vyxeos without reference to its investigational nature, Celator also strayed in its description of the drug's benefits.
The poster included bullet points saying: "in vitro research has shown that a 5:1 ratio of cytarabine-daunorubicin delivers optimal anti-cancer activity" and "a completed Phase 3 study demonstrated improved survival for Vyxeos compared to '7+3' in newly diagnosed patients with high-risk AML."
The OPDP took issue with the use of the word "optimal" and Celator's claim Vyxeos improved survival rates over chemotherapy (7+3 refers to a type of chemo regimen).
"These claims suggest that CPX-351... is effective for the treatment of cancer generally and newly diagnosed patients with high-risk AML specifically, when it has not been approved for these uses," the OPDP wrote in its letter.
While the OPDP has only issued three letters so far this year, the low level of activity hasn't always been the case.
Eye on the FDA, a blog run by a Washington, DC-based lawyer at the firm Fleishman Hillard, has kept track of ODPD letters over time. According to the blog, the OPDP sent a total of nine "warning" and "untitled" letters to drugmakers in both 2014 and 2015. That was down substantially from the 52 sent in 2010 and a shadow of the 156 letters issued in 1998, the highest number over the last 20 years.
With only three letters sent through the eight months of the year, 2016 looks like it may hit a new low.
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