FDA-Ok’d Drugs W/ Biomarkers Growing

Targeted drugs, personalized medicine, stratified therapy–whatever you call it, using biomarkers to identify particular patients for particular drugs has been hailed as a boon for patients and a savvy strategy for pharma.

Advocates can talk up approval numbers, labeling changes and Phase III therapies. But it’s according to the 80/20 rule: A small number of pharma companies account for the lion’s share of targeted meds. And the star of personalized medicine is just the company you’d expect: Roche ($RHHBY), with its drug-plus-diagnostic approach to cancer R&D, its stable of blockbuster HER2-positive therapies, and a total of almost $20 billion in sales from its targeted drugs.

Just ask Diaceutics, the U.K. research firm, which keeps close tabs ondiagnostics-aided medicine. Yes, the number of FDA-approved drugs linked with a particular biomarker has leapt over the past three years, to more than 80 from just over 20. And while only 7 new drugs with companion diagnostics have made their market debuts, 53 others have new FDA labeling that flags safety-related biomarkers–bringing the percentage of targeted therapies on the market to 19% from 6% in 2010.

This blog post was originally written by Tracy Staton with the title Who are the stars of personalized meds? Roche, Novartis and J&J