A study by scientists from the USA, Canada, and the UK revealed that of 89 new oncology therapies approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) between 2010 and 2019, 95% were approved by the American agency first, with EU market authorization granted an average of 241 days later.<\/p>\n\n\n\n

The results were published<\/mark><\/a> in the journal JAMA Network Open<\/em>. According to the study’s lead author, pharmacologist Mark Lythgoe of Imperial College London, the European “delay” remains relatively unchanged from a decade ago. But an eight-month gap is highly significant, exceeding the life expectancy of many people with advanced cancer, the British expert stresses.<\/p>\n\n\n\n

\u201cThe FDA\u2019s accelerated approval process has provided access to many innovative drugs that have positively transformed the lives of thousands of patients,\u201d Lythgoe told ScienceArena<\/strong><\/strong>. As an example, he highlights the antitumor medication imatinib\u2014currently sold under the brand name Gleevec by multinational pharmaceutical company Novartis\u2014which has revolutionized the treatment of chronic myeloid leukemia, a rare type of cancer that affects blood cells.<\/p>\n\n\n\n

\u201cFaster approval, however, is a double-edged sword,\u201d says the scientist. The FDA has had to subsequently withdraw more newly approved cancer drugs from the market than the EMA. This may suggest that shorter evaluation processes do not always translate into better results.<\/p>\n\n\n\n

Lythgoe mentions another JAMA<\/em> <\/mark>study<\/mark><\/a>, published in 2019, which showed that of 93 cancer drugs granted accelerated approval by the FDA, only 19 (20%) led to improved survival. \u201cApproval speed and volume should only be celebrated if they deliver more significant results, giving the patient a better and longer life,\u201d says Lythgoe.<\/p>\n\n\n\n

Ali Raza Khaki, an oncologist at Stanford University School of Medicine, California, and coauthor of the paper, emphasizes that the group’s findings cannot be directly related to the amount of bureaucracy involved at the regulatory agencies or the level of caution with which decisions are made.<\/p>\n\n\n\n