For the fourth year running, personalized medicines have made up more than 20 percent of new drugs approved by the US Food and Drug Administration, according to a new report from the Personalized Medicine Coalition.
In all, the report says the agency approved 19 personalized medicines — including three gene therapies — in 2017, noting that's the highest number of personalized medicines to garner approval in a year. These newly approved therapeutics include Novartis' Kisqali (ribociclib), Neurocrine Biosciences' Ingrezza (valbenazine), and AbbVie's Mavyret (glecaprevir and pibrentasvir). GenomeWeb's Turna Ray likewise has reported that FDA approved 19 personalized medicines in 2017, as compared to 14 in 2016 and about a dozen in 2015.
PMC also notes that the FDA approved a number of new indications for already-existing drugs, such as Merck's Keytruda (pembrolizumab), Bristol-Myers Squibb's Opdivo (nivolumab), and Novartis' Tasigna (nilotinib), among others. It says the expanded indication of Keytruda "is particularly significant" since it's the first time that a tissue-agnostic cancer drug has been approved.
This boost in approvals, PMC President Edward Abrahams says in a statement, suggests "FDA is increasingly committed to supporting" targeted therapies.