In 1992 FDA introduced the Accelerated Approval Subpart H into the new drug approval process and in 1995 extended its application to oncology drugs. This allows accelerated approval of drugs for serious or life-threatening diseases if they appear to provide a benefit over available therapy based on a surrogate endpoint that is “reasonably likely to predict clinical benefit”. Use of such a surrogate generally allows smaller and quicker trials as the surrogates mature faster than endpoints like Overall Survival (OS), so Subpart H facilitated potential earlier marketing of useful drugs. By 2006 30 oncology drugs, including biologics, had been given accelerated approvals and, from thalidomide for multiple myeloma in May 2006 through nilotinib
