PRESCRIBING CHANGES IN RESPONSE TO US FOOD AND DRUG ADMINISTRATION ACCELERATED VS. REGULAR APPROVAL OF ONCOLOGY THERAPIES

2025
Research Categories

Prescribing Changes in Response to US FDA Accelerated vs. Regular Approval of Oncology Therapies

Ravi B. Parikh, MD, MPP; Ernesto Ulloa Perez, PhD; Martin Kurian; Rebecca Hubbard, PhD; Steven Joffe, MD, MPH; Holly Fernandez Lynch, JD, MBE; Ronac Mamtani, MD

This white paper examines real-world prescribing patterns and policy implications following FDA accelerated versus regular approval of oncology therapies. Using Flatiron Health’s national electronic health record cohort (63,434 patients, 2011–2024), the study evaluates how prescribing changes after accelerated approval (AA) and subsequent regular approval (RA) for cancer drugs.

Key findings include:

  • Substantial increases in prescribing occur immediately after AA, while post-RA changes are modest.

  • Indications later granted full approval see the greatest early adoption.

  • Off-label use remains rare, suggesting cautious clinical practice despite provisional evidence.

  • The results highlight the urgent need for timely confirmatory trials and policy reforms to ensure rapid generation of robust clinical evidence.

The analysis informs ongoing FDA reforms and provides critical insight for oncologists, policy makers, and manufacturers navigating accelerated drug approval pathways.

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