Expert Blasts FDA Labeling of Cancer Drugs

SEPTEMBER 19, 2011
Instructing patients to take oral anticancer medications without food is a costly, risky move, says pharmacology specialist.

Taking oral anticancer medications without food is akin to “flushing costly medicines down the toilet,” wrote cancer drug dosing specialist Mark Ratain, MD, in a commentary published in the September 19 online issue of the Journal of Clinical Oncology.

The wasteful practice—which is perpetuated by the FDA's “systematic preference” for labeling oncology drugs under fasting conditions—also puts patients at increased risk for an overdose, argued Dr. Ratain, the Leon O. Jacobson professor of medicine and director of the Center for Personalized Therapeutics at the University of Chicago Medical Center. He has written previously about the cost implications of interactions between cancer drugs and food.

“Instead of taking high doses on an empty stomach—which is how most of these drugs are labeled—patients would be better off taking much lower doses along with a meal,” Dr. Ratain stated in a press release. The new approach to labeling oral oncolytics would yield substantial benefits for payers, providers, and patients: “This could reduce the risks of an overdose, save money, and give patients more control over their daily lives,” he said.

In the recent commentary, Dr. Ratain cited abiraterone acetate as an example of a new oral anticancer drug that has greater bioavailability when administered with food. Approved under the brand name ZYTIGA on April 28, 2011, for the treatment of metastatic prostate cancer, abiraterone has the “greatest food effect of any marketed drug, yet it is labeled to be taken fasting,” said Dr. Ratain. Taken without food, roughly 77% of the administered drug—about $5,000 a month—is “literally wasted. It gets excreted and flushed away,” he elaborated.

Given the high attrition rate for cancer drugs, the author asked, “do we really need to flush our few successful products down the toilet?”

Waste concerns are dwarfed by the potential for overdose with the current labeling, according to the author. Should a patient make the simple mistake of eating 30 minutes after taking a standard fasting dose of 1,000 mg, he or she would receive 5 to 10 times the intended dose of abiraterone. If patients were to take the drug with a light breakfast instead, the estimated monthly savings per patient would be $3,750, Dr. Ratain noted.

He stressed that patients should not attempt the switch on their own, and that any transition to better dosing instructions for oral anticancer drugs would require broad systemic change. But the change is urgently needed, said the specialist. FDA’s current approach is inconsistent with other drug categories, “and with the fundamental principles of clinical pharmacology,” he wrote.

For more on the specialty pharmacist’s role in navigating issues with oral oncology agents, see the following articles from Specialty Pharmacy Times:

For other articles in this issue, see:

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