In the 1980s, only 4% of new drugs approved by the FDA were cancer treatments. But since 2010, cancer drugs have claimed 27% of new approvals—a share that doubled over the previous decade—according to a new report from the Tufts Center for the Study of Drug Development.
Why the surge in oncology successes? Because pharmaceutical companies have taken a new approach to drug development, focusing on pursuing novel mechanisms for treating cancer and validating them with clinical trials that are much better designed than they were in the past.
Couple that with an FDA that has doubled down on its efforts to speed medicines to market that address unmet medical needs, and the result is a flood of new cancer drugs, the Tufts report concluded.
According to Tufts, the development timeline for cancer drugs was 9% longer than it was in other diseases between 1999 and 2018, but the time it took for the FDA to approve cancer drugs was a whopping 48% shorter on average. That’s because new oncology products were far more likely to receive special designations from the FDA designed to speed up the regulatory process, including orphan drug designations and priority reviews, according to a summary (PDF) of the Tufts report.
The Tufts analysts emphasized that the pharmaceutical industry has become smarter when it comes to identifying new targets for treating cancer—gene mutations and the like—developing drugs to target them and then designing clinical trials around the patients who are most likely to respond to those medicines.
Indeed, several of the drugs approved over the last decade have been designed to inhibit cancer-driving protein kinases like Bruton’s tyrosine kinase, NTRK, BRAF and MEK. A recent analysis by Wall Street firm SVB Leerink found that kinase inhibitors have driven nearly $100 billion in mergers and acquisitions since 2010.
SVB Leerink also pointed to the FDA’s speedy review of cancer drugs as a major factor driving the pharma industry’s interest in kinase inhibitors. In fact, 77% of kinase inhibitors were evaluated under priority review, and the FDA gave some of them the coveted “breakthrough” therapy designation, which can accelerate approvals even further.
The flip side to all the enthusiasm over cancer drug development is that it doesn’t come cheap—either for the pharma companies inventing these new products or for the healthcare system. Tufts has estimated that the total cost of developing any prescription drug is nearly $3 billion. (It’s an estimate that has come with its share of controversy, though.) And oncology drug developers spend an average of $13 million just on the launch phase for a single cancer drug in one indication, according to a recent Best Practices survey of 12 pharma companies including Amgen, Bayer and Novartis.
The need for companies to try to recoup those expenses on the back end often drives high prices for payers and patients. In 2018, spending on cancer drugs increased by double digits for the fifth straight year. The 15 oncology drugs approved in 2018 came with a median annual cost of $149,000.
For now, pharma companies will continue to respond to the demand for innovative cancer drugs, and, in so doing, they’ll have to juggle cost pressures from all sides, Joseph DiMasi, Ph.D., research associate professor and director of economic analysis and at the Tufts Center for the Study of Drug Development, predicts.
“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.
By Arlene Weintraub
Source: Fierce Pharma
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