Cancer drug approvals in the U.S. have surged over the past few decades

Reflecting an intensifying effort to conquer cancer, the portion of new oncology treatments approved by the Food and Drug Administration swelled over the past decade, reaching 27% of all drug approvals compared with just 4% during the 1980s, according to a new analysis.

Between 2010 and 2018, FDA approvals for cancer therapies outstripped endorsements for antibiotics and drugs used to treat central nervous system disorders and cardiovascular ills, all of which are also major therapeutic categories. In fact, approvals for anti-infective and cardiovascular drugs fell notably, while approvals for central nervous system drugs remained stable. In all, the FDA approved 126 cancer medicines during that time.

“New approaches to development helped to drive the surge in new oncology products, including improvements in clinical trial design, novel drug formats, and a focus on new and validated targets,” explained Joseph DiMasi, research associate professor and director of economic analysis at the Tufts Center for the Study of Drug Development, which ran the analysis.

The findings are not surprising, given the sustained interest in combating cancer and the subsequent increased investments by the pharmaceutical industry. The betting has been heightened by the success of many immunotherapies, which harnesses the body’s own immune system to beat back cancerous cells, in fighting several different cancers.

At the same time, the FDA has been responding not only to advances in science, but commensurate pressure from patients and lawmakers to increase the rate and actual numbers of approvals.

Numbers help to tell the story.

Approval rates for drugs that tackle solid tumors increased from 1.6 a year from 1999 to 2003 to 6.6 a year between 2014 and 2018. Hematologic cancer drug approvals also increased, although only more recently — from 2.6 a year between 2009 and 2013 to 4.2 a year since then.

Looked at another way, the average annual approval rate for cancer drugs was 6.3, with 3.7 approvals issued for solid tumor cancers and 2.6 for hematologic cancers, according to Tufts. Notably, over the 20 years that were examined, 45% of solid tumor and 40% of hematologic cancer drugs approvals occurred in just the past five years.

Meanwhile, the mean clinical development time for cancer drug approvals compared to other medicines varied considerably, although it has been declining. The difference in time was as high as 21%, or 1.4 years longer, from 2004 to 2008, to 7%, or six months shorter, between 2014 and 2018.

Separately, the mean clinical development time for cancer drugs increased from a low of 6.9 years from 1993 to 2003 to a high of 8.2 years between 2004 and 2008, but fell back to 6.9 years since 2014.

This is likely to continue to fluctuate. “Developers will be challenged to control development costs, particularly those tied to recruiting sufficient numbers of patients for clinical trials involving rare cancers, and manage payer pressure to control drug prices and contain pharmaceutical spending in the U.S.,” DiMasi said in a statement.

Here are some more numbers.

Between 1999 and 2018, the mean approval time for cancer drugs was 8 months, or 48% less than for other medicines. The mean cancer drug approval time fell from a high of 14.2 months at the start of the study period to a low of 6.5 months between 2009 and 2013. The mean approval time for other drugs decreased from 18.2 months in 1999 and 2003 to a low of 12.6 months over the past five years.

Here’s another nugget: From 1999 to 2018, nearly twice as many new cancer drug approvals received a priority rating from the FDA, compared to approvals for medicines to treat other illnesses — 82.4% versus 43.6%, respectively.

During the same period, 70% of new cancer drugs were granted orphan drug status for the original approved indication, compared to just 25% for other new treatments. The share of cancer drug approvals with an orphan drug designation varied between 60% and 80% over each of the five-year study periods, but more than doubled for other medicines, from 15.6% to 35.5%.