In the 1990s, so-called drug cocktails produced major results in the treatment of AIDS. Now researchers are working a new generation of combination medicines to fight cancer. In response, U.S. drug regulators are rewriting the rules for drug approval to help usher in better treatments and cut development time Bloomberg Businessweek reports.
Five years ago, the U.S. Food and Drug administration required that each active ingredient in a drug had to be approved before it could be added to another medication, to prevent combinations in which one ingredient didn’t help, or even caused harm.
But advances in the understanding of of the cellular and genetic roles in disease has convinced the FDA to allow new testing of drug cocktails to fight cancer.
The anticipated FDA guidelines, which have not yet been released to the public, have three basic principles, the AP reports:
First, there should be a scientific rationale for how the drugs will work together in the body. Second, there should be evidence from mouse tests or small human trials that the benefit of combining the drugs is more than additive (think 1+1=3). Finally, there should be a compelling reason why each drug can’t be successful independently.
If conditions are met, companies can test the drug cocktail–instead of having a trial for each individual drug–during phase III trials, the last and most expensive trials required for FDA approval.
Roche, the world’s biggest maker of cancer medicine and Pfizer, the world’s biggest pharmaceutical company both have drug cocktails in human trials.
