A new study is questioning whether accelerated approvals for cancer drugs have benefitted patients. In 2012, Congress approved legislation that included the Breakthrough Therapy (BT) Program, in which promising drugs for serious or life-threatening diseases receive an expedited review and approval process. Researchers analyzed the efficacy and safety of cancer drugs approved through the program and compared findings with those associated with non-breakthrough drugs approved through 2017. Of the 58 new cancer drugs approved, 25 received the BT designation. The study examined 7,000 patients treated with BTs and around 12,000 patients treated with drugs that did not receive the designation. The results found that BTs did not offer substantially improved efficacy or safety when compared with non-breakthrough drugs. Around 38% of patients experienced serious adverse events while being treated with BT drugs, while 36% of those treated with non-BT drugs experienced serious side effects. Additionally, death unrelated to the progression of disease was 6% for BT drugs and 4% for non-BT drugs. Posted June 20, 2018. Via Journal of Clinical Oncology.