HoffmannNWBO stands on the verge of their first regulatory authority approval of an anticancer drug with a novel mechanism of action (“MoA”). A few data points about the long odds #DCVax-L faced in the path towards approval.
Approvals
“When examining individual drugs across tumor types, 195 approvals (59%) were subsequent approvals of the same drug, 84 (25%) were first approvals of a next-in-class drug, and 53 (16%) were approved based on a new mechanism of action (Figure 2A). While classifying approvals by indication (a drug can be novel in a different tumor type, if first approved for another), 106 (32%) approvals were subsequent approvals of the same drug in the same tumor type, 103 (31%) were first approvals within 1 tumor type of a next-in-class drug, while 123 (37%) drugs were approved based on a new mechanism of action in a new tumor type (Figure 2B).” [1] (emphasis added) ^^ See Image 1.
Lack of Incentive
“Despite an increase in absolute number, approvals based on a new mechanism of action remain a minority of all approvals. Next-in-class drugs may provide benefit. They also have the potential to divert research and drug development from true innovation and to contribute to the increasing burden of cost of anticancer drugs. Furthermore, they often provide limited data about efficacy in comparison with their first-in-class compound, with shorter safety evaluations. Future research should consider incentives to encourage the pursuit of novel therapeutic targets.” [1] (emphasis added)
“A study conducted by Mailankody and Prasad on the cost of anticancer FDA-approved drugs between 2009 and 2013 found no difference in median prices between next-in-class and novel mechanism of action drugs, suggesting that there may be underincentivization for the pharmaceutical industry to develop first-in-class compounds.” [2] (emphasis added) Costs “The R&D spending on novel drugs was higher than next-in-class drugs (median, $899.2 million [range, $328.1 million to $1950.8 million] vs $473.3 million [range, $157.3 million to $815.8 million]; P = .047).” [3] (emphasis added)
NWBO’s MoA presentation
