Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia.
Thomas J HwangAaron S KesselheimAriadna TibauChangWon C LeeKerstin N VokingerPublished in: JCO oncology practice (2022)
Most new cancer therapies were approved first by the FDA, and delays in submission of regulatory applications accounted for substantial delays in approving cancer drugs in other countries. Regulators should prioritize faster review for drugs with high clinical benefit.