The FDA is urging drug companies to pinpoint the cancer drug dosage that has the greatest impact with the fewest side effects. Its most recent study scrutinizes the dosage of a lung cancer drug, The Washington Post reported May 6.
Typically, companies spend the first series of drug trials escalating doses in small groups of patients until about a quarter of them become seriously ill. That "maximum tolerated dose" is used in more advanced clinical trials and tends to make it to the drug's label, according to the report. However, the FDA is asking companies to reassess.
The presence of more side effects means more patients become ill and skip doses or stop taking drugs altogether. In some cases, a quarter-dose could be nearly as effective and cost significantly less, a study by Amgen at the behest of the FDA found.
Amgen is the maker of lung cancer drug Lumakras. The FDA gave the drug conditional approval but required the company to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial showed the higher dosage may give patients one more month of life but cause more severe side effects.
Amgen said it will keep the 960 mg dosage as it conducts further tests. Last year, Lumakras brought in nearly $200 million in revenue to the company, and the higher dose makes four times as much revenue per patient from Medicare, according to the report.
University of Chicago oncologist Mark Ratain, MD, a critic of Amgen, told CMS that Medicare should pay for the drug on the basis of a 240 mg daily dosage, but CMS said it would only do so "if there is a change in the drug’s FDA-approved dosage."
The Amgen study was part of the FDA's Project Optimus, which is aimed at making cancer drugs less toxic and more effective. The project began in 2021.