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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 proportion that has doubled from the previous decade, according to a new report from the Tufts Center for Drug Development Studies.
Why the rise of success in oncology? Because pharmaceutical companies have adopted a new approach to drug development, focusing on finding new cancer treatment mechanisms and validating them through clinical trials that are better designed than in the past.
Add to that an FDA that has doubled its efforts to speed up the marketing of drugs that address unmet medical needs and result in a flood of new anti-cancer drugs, the Tufts report concluded.
According to Tufts, the development time of anticancer drugs was 9% longer than in other diseases between 1999 and 2018, but the time required for the FDA to approve anticancer drugs was significantly reduced by 48% on average . According to a Tufts report summary (PDF), new oncology products were much more likely to receive special FDA designations designed to speed up the regulatory process, including orphan drug designations and revisions of priorities.
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Tufts analysts pointed out that the pharmaceutical industry has become smarter in identifying new targets for cancer treatment – genetic mutations, and so on. – developing drugs to target them, then designing clinical trials of patients most likely to respond to these drugs. .
Indeed, many of the drugs approved in the past decade have been designed to inhibit cancer-inducing protein kinases, such as Bruton tyrosine kinase, NTRK, BRAF and MEK. A recent study by Wall Street's SVB Leerink found that kinase inhibitors have generated nearly $ 100 billion in mergers and acquisitions since 2010.
SVB Leerink also pointed out that FDA's rapid review of anti-cancer drugs was an important factor in the pharmaceutical industry's interest in kinase inhibitors. In fact, 77% of kinase inhibitors have been evaluated as a priority and the FDA has attributed to some of them the designation of "revolutionary" treatment so coveted, which can further accelerate approvals.
The excitement of developing cancer drugs is that it is not cheap for pharmaceutical companies that invent these new products or for the health system. Tufts estimated that the total cost of developing a prescription drug is close to $ 3 billion. (This is an estimate that has however sparked much controversy.) And the developers of oncology drugs spend an average of $ 13 million just for the launch phase of an anti-cancer drug in an indication, according to one recent best practice survey of 12 pharmaceutical companies. among which Amgen, Bayer and Novartis.
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The need for companies to try to recover these downstream expenses often results in high prices for payers and patients. In 2018, spending on cancer drugs increased to double digits for the fifth year in a row. The 15 approved oncology drugs in 2018 have a median annual cost of $ 149,000.
For the time being, pharmaceutical companies will continue to meet the demand for innovative cancer drugs and, in the process, they will face financial pressures from all sides, Joseph DiMasi, Ph.D., associate professor of research and director of the department. economic research. analysis and at the Tufts Center for the Study of Drug Development, predicts.
"Developers will be challenged to control development costs, particularly those related to recruiting a sufficient number of patients for clinical trials involving rare cancers, and to manage the pressure of payers to control the prices of drugs and contain pharmaceutical spending in the United States, "DiMasi said in a statement.
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