Priority Review:
Six-Year Trends and Strategic Insights
Priority Review
Priority Review is an FDA designation that shortens the review time for a drug application from the standard 10 months to 6 months. It is granted to drugs that could offer major advances in treating, diagnosing, or preventing serious conditions, such as improved effectiveness, better safety, fewer side effects, or benefits for new patient groups. While companies may request it, the FDA makes the final decision within 60 days of application submission. Priority Review speeds evaluation but does not change approval standards or clinical trial requirements.
Priority Review Over the Past Six Years (2020–2025)
The trend in Priority Review designations over the past six years shows fluctuating but overall steady regulatory activity, with notable peaks and declines reflecting shifts in therapeutic innovation cycles and submission volumes. The number of Priority Reviews rose from 30 in 2020 to a peak of 34 in 2021, followed by a sharp decline to 21 in 2022. Activity rebounded in 2023 with 31 designations, before easing slightly to 28 in 2024 and further declining to 21 in 2025, returning to the lowest level observed in the period alongside 2022.
Overall, the trend suggests periodic surges likely driven by waves of oncology, rare disease, and advanced therapy submissions, followed by normalisation phases.
In 2025, Priority Review designations continued to be dominated by high-impact therapeutic areas, including oncology, rare diseases, and advanced biologics. Notable examples include approvals of targeted cancer therapies addressing solid tumours and hematologic malignancies, as well as novel treatments for rare genetic disorders and next-generation immunotherapies, all of which were prioritised due to their potential to offer substantial improvements over the existing standard of care.
A few of the key examples from 2025 were:
- Datopotamab deruxtecan (Datroway) – received Priority Review designation for advanced breast and lung cancers.
- Revumenib – received Priority Review designation for NPM1-mutant acute myeloid leukemia.
- Vimseltinib (Romvimza) – received Priority Review designation for tenosynovial giant cell tumor, all representing precision oncology advances targeting specific molecular or tumor subtypes.
- Suzetrigine (Journavx) – stood out as a first-in-class non-opioid therapy for acute pain.
- Aficamten (Myqorzo) – marked a major cardiovascular advance for obstructive hypertrophic cardiomyopathy.
8Six-Year Trend in Priority Review (2020–2025)
Fig 4: Priority Review trends