In 2021, FDA approved more than 60 oncology drugs and biologics including dangling accelerated Approvals, drug dosing, new approvals and more. This recently published article coauthored by FDA’s Steven Lemery and Richard Pazdur provides a nice summary of FDA Oncology’s 2021 policy priorities and approvals. Policy areas of focus included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric antigen receptor T cell products, two antibody–drug conjugates and several new targeted agents. While most of the new molecular entities approved as targeted therapies were for rare diseases, progress is being made on many fronts. Cancer patients as well as the biopharmaceutical industry can look forward to more progress in the current year and beyond.