FDA considers new rules to speed up confirmatory studies of cancer drugs granted accelerated approval

Since 1992 the U.S. has administration food and drug indications for 35 cancer drugs and in more than half of the cases later granted approval to 47 - 26 indications accelerated - further studies confirm the benefits of drugs. But the Agency concerns about the length of time that remained some drugs on the market without confirmation of their services, according to a review article has published in the journal of the National Cancer Institute online March 25. New requirements and fines are possible solutions say the authors of the FDA Office of Oncology medicines.

John R. Johnson, m.d., and colleagues the FDA reviewed experience with the fast-track approval from its beginnings in 1992 to July 2010. Among the 26 indications, which eventually received the regular approval, the median time between accelerated approval and regular approval was 3.9 years and the average time was 4.7 years. This "significant time savings for the earlier availability of drugs patients" represent, the authors write.

But three were placed under taken or very limited patient distribution from the market, because subsequent attempts will not confirm an advantage. Two were on the market for 10 years before will be withdrawn. Fourteen accelerated approvals have still not completed confirmatory studies; one of these drugs has been on the market for 10.5 years and have three for over 5 years was marketed. And among the information that have converted to regular admission of accelerated approval took five more than 7 years completed confirmatory studies with 12.6 years and takes another 9.7 years.

"Because of the possibility that confirmatory studies are, confirm indications that should have received on the market for studies completed to be unacceptably long intervals in the absence of accelerated approval not clinical benefit" write the authors. They suggest that a solution to this problem for the FDA requires, that is a confirmatory study underway, is prior to the granting of the accelerated approval. Another is from the food, drug, and Cosmetic Act of 2007, which gave FDA the authority to fine make companies up to $10 million for lack of due diligence in the completed confirmatory studies. "The FDA believes that this is an effective new tool", the authors conclude.

In an accompanying editorial, Susan S. Ellenberg, PhD., from the University of Pennsylvania School of medicine in Philadelphia, are notes, which analyses such as these essential in improving the regulatory process. It describes some issues that not fully review, are addressed, that actually accelerates most important of which is extent the availability of the products to the accelerated approval. Ellenberg, argued that the time as the time, a study for the first accelerated approval and then do a second, confirmatory study would be probably shorter to complete a study, which was addressed on regular admission of beginning. "So the time availability of a new drug, although undoubtedly shorter with accelerated approval as an option, beat may not as impressive as Johnson et al.."

The Editorialist adds that the FDA initiative announced last new regulatory science fall "analysis of the regulatory data incoming more should support, which could provide valuable insights for improving the regulatory approaches."

Source code
The journal of the National Cancer Institute