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Cancer drugs account for 27% of all new drug approvals in the U.S., says Tufts

From 1980 through 2018, the FDA approved a total of 126 cancer drugs to treat solid and hematologic tumors.

Jeff Lagasse, Associate Editor

Cancer drugs currently account for 27% of all new drug approvals in the U.S. since 2010, a dramatic increase from the 4% share of the 1980s, a newly completed analysis from the Tufts Center for the Study of Drug Development shows.

From 1980 through 2018, the Food and Drug Administration approved a total of 126 cancer drugs to treat solid and hematologic tumors.

Joseph A. DiMasi, research associate professor and director of economic analysis at Tufts CSDD, said the surge in new oncology products is due to new approaches to development -- efforts which have paid off in the form of more effective treatment options.


Pressure for even more oncology drugs is likely to continue, the analysis showed, given that there are still many cancers that are inadequately treated, or untreatable altogether.

Developers will be challenged to control development costs, especially those linked to recruiting enough patients for clinical trials involving rate cancers. There will also be pressure from payers to control drug prices and contain pharmaceutical spending.

The analysis also found that clinical development time for cancer drug approvals from 1999 to 2018 was 9% longer compared to non-cancer drugs.

Regulatory approval phase time for cancer approvals during that time period was 48% shorter on average compared to non-cancer approvals, while total clinical development and approval phase times was 17% longer on average for hematologic drugs (8.8 years) compared to drugs for solid tumors (7.5 years).

Meanwhile, substantially higher percentages of new cancer drug approvals received priority ratings from the FDA and had orphan drug status, compared to new non-cancer drug approvals.


Health systems, including inpatient and non-acute environments, can expect a 4.57% increase in pharmaceutical spend for 2020. Vizient, which revealed that finding in its recent 2019 Drug Price Forecast, predicts a continued growth of pharmaceutical costs that far exceeds both inflation and wage growth.

Pharmaceutical costs are already a large share of most health organizations' budgets, and this is unlikely to change.

There are a number of factors contributing to this trend -- for one, specialty drug price inflation. Overall, the predicted total specialty inflation rate of 4.23% is similar to the general drug inflation rate of 4.57%. But this new price projection is important for health system leaders since prices of specialty drugs tend to outweigh prices for non-specialty medications. This inflation rate will likely result in the need for providers to increase their drug budgets in the coming year.

Drug shortages, which of course compromise patient care, will likely contribute both directly and indirectly to overall higher costs.

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