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More and More Personalized Drugs

More than 40 percent of new drugs approved by the US Food and Drug Administration in 2018 were personalized medicines, according to an analysis by the Personalized Medicine Coalition.

These 25 new personalized medicine drugs include Vitrakvi (larotrectinib) and Onpattro (patisiran), PMC notes. Vitrakvi, a TRK inhibitor from Loxo Oncology, is the second cancer drug to be approved based on a biomarker — an NTRK gene fusion — rather than tumor type. Alnylam's Onpattro, meanwhile, is the first small interfering ribonucleic acid (siRNA) treatment to be approved. These approvals illustrate the emerging trends of biomarker-defined treatments and siRNA-based therapies, PMC says.

In its report, PMC also highlight challenges facing personalized medicine, including the need for sufficient FDA funding and changes to a reimbursement system it says is tied to "one-size-fits-all medicine." It argues that new policies such as the Centers for Medicare and Medicaid Services' plan to implement step therapy to physician-administered Part B drugs are hindering the adopting of personalized treatments, as patients would be required to try less expensive, standard treatments first.

"[I]t falls on Congress, the Centers for Medicare and Medicaid Services (CMS), and FDA to continue implementing public policies that recognize the principles of the field, which are responsible for the burst of innovation that the report documents," PMC President Edward Abrahams says in a statement