Cancer drugs have surged since the 80s to account for 1 in 4 FDA approvals, report reveals

pharmafile | September 5, 2019 | News story | Research and Development, Sales and Marketing Cancer, FDA, US, pharma 

The number of cancer drug approvals in the US has surged over the last decade to account for over one in four of all therapy authorisations from the FDA, according to a new report form the Tufts Center for the Study of Drug Development.

The report notes that, during the 1980s, cancer drugs only claimed a 4% share of all US drug approvals, but this has rocketed to account for 27% since 2010. Between 1980 and 2018, the FDA has approved a total of 126 cancer therapies for the treatment of solid and haematologic tumours.

Reasons for this stark improvement are various: drug development has taken a new approach over the years, with a focus on novel mechanisms which are then tested through more robustly-designed clinical trials which recruit only patients who are most likely to respond to the test therapy.

Additionally, the FDA has shifted its approach to accelerate the authorisation of medicines which address unmet need, especially cancer therapies: the report notes that, between 1999 and 2018, development time for cancer drugs was 9% longer than those in other diseases, but were approved almost twice as quickly (48%) as others, as they were much more likely to secure accelerated regulatory designations.  

“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,” remarked Joseph A DiMasi, Research Associate Professor and Director of Economic Analysis at Tufts CSDD. “Those efforts appear to have paid off, as cancer patients today have many more effective treatment options.

“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 US,” he added.

Matt Fellows

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