Any drug or pharmaceutical product is approved for marketing once it succeeds in the adequate and well-controlled phase III trial. Marketing approval of drugs, provided by the US Food and Drug Administration (FDA), could be granted provided the safety, as well as efficacy measures, has been taken care of. Regular approval was the sole mandate of the US FDA until 1992. Eventually, in the context of the Human Immunodeficiency Virus (HIV) crisis, the addition of subpart H to federal regulation paved the way for accelerated approval (AA) as an alternative pathway. It promotes the new drug as having a more meaningful advantage over already approved minuscule drugs in the context of a serious or life-threatening rare condition. It is followed by post-approval studies, which ascertain the clinical benefit as well as risk profile in a more sophisticated way. AA can be revoked if the confirmatory trial is suspended or depicts risk outweighing the benefit. As an example, the approval of bevacizumab for the treatment of metastatic breast cancer was revoked in 2011 as it failed to demonstrate a benefit in overall survival (OS).

The accelerated approval (AA) pathway has paved the way for many of the novel drugs used in oncology in recent years, which seems likely to continue in the near future. However, there are certain issues that may lead to various dilemmas in the process. Therefore, the specific issues involving study methodology as well as regulatory issues of this process need further clarification to avert various dilemma.