Formulary Files

FDA approval of oncology drug indications, 1949-2015

Between 1949 and mid-2015, the FDA approved nearly 300 unique indications for oncology drugs, which works out to an average of 4.4 indications per year.

This number includes the indications for which a drug was approved initially and any supplemental oncologic indications for which it was approved at a later date.

Initial and supplemental indications

The overall average may mask the fact that the pace of approvals has picked up dramatically in recent years. Four times as many indications for cancer drugs have been granted in the past 25 years than in the four decades prior to 1990.

Approved indications per year


Six broad categories of cancer (lower chart) account for 70% of the indications. This is not at all surprising because both with respect to incidence and to mortality, those six categories rank among the top 10 cancers in the United States.

Leading categories of oncologic drug indications

Number of indications

American Cancer Society, “Cancer Facts & Figures 2015”; Martell RE et al., Oncologist, January 2013; Managed Care research.

Across the entire 66-year period, the development of new cancer drugs has been focused on advanced disease, with four fifths of the FDA-approved indications being for advanced cancer.

It should also be noted that the use of these cancer-fighting medications extends far beyond the FDA-approved indications. Off-label use of cancer drugs is quite common in clinical practice.

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