Regulatory Focus™ > News Articles > Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016

Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016

Posted 06 September 2016 | By Zachary Brennan 

Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016

In just its third untitled letter of the year (and the first in almost five months), the US Food and Drug Administration (FDA) on Tuesday called out Jazz Pharmaceuticals subsidiary Celator Pharmaceuticals for promoting an investigational drug in a panel at the American Society of Clinical Oncology’s (ASCO) annual meeting in June.

The company promoted the investigational drug, which was previously granted a breakthrough therapy designation by FDA, with claims that it is “as safe and effective for the purposes for which it is being investigated or otherwise promote the drug, including the following: · VYXEOS · In vitro research has shown that a 5:1 ratio of cytarabine-daunorubicin delivers optimal anti-cancer activity. · A completed Phase 3 study demonstrated improved survival for VYXEOS™ compared to ‘7+3’ in newly diagnosed patients with high-risk AML.”

FDA says the claims suggest that “CPX-351 (labeled on the ASCO panel only with the proprietary name ‘VYXEOSTM’) is effective for the treatment of cancer generally and newly diagnosed patients with high-risk AML [acute myeloid leukemia] specifically, when it has not been approved for these uses.”

Furthermore, FDA says the claims and presentation “make conclusions that the drug has been proven to be ‘optimal” for the treatment of cancer and improves survival relative to ‘7+3’ chemotherapy in newly diagnosed patients with high-risk AML, when FDA has not approved CPX-351 for any use.”

The cited references for Celator’s presentation include preclinical studies exploring the synergistic effects of various drug combinations at different ratios and an analysis of the drug ratio-dependent synergy of cytarabine:daunorubicin in various cell lines and in mouse models, FDA says.

However, “neither of these studies support claims of efficacy in human patients with cancer generally or high-risk AML specifically. We note that the ASCO panel and the area surrounding the display did not include any information to indicate that CPX-351 is an investigational drug product that has not been approved for commercial distribution in the United States and that this panel appeared in the main exhibit hall at ASCO, alongside approved products.”

FDA’s Office of Prescription Drug Promotion requests that Celator immediately cease violating the FD&C Act and stop disseminating such promotional materials, and to submit a written response to this letter on or before 9 September 2016, stating whether the company intends to comply and explaining a plan for discontinuing use of such violative materials.

Jazz did not respond to a request for comment.

Untitled Letter


Categories: Regulatory News

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