About a quarter of new drugs approved in 2019 by the US Food and Drug Administration were personalized drugs, according to an analysis by the Personalized Medicine Coalition.
These 11 newly approved personalized medicines include alpelisib (Novartis' Piqray) to treat advanced or metastatic breast cancer in combination with fulvestrant; golodirsen (Sarepta Therapeutics' Vyondys 53) to treat Duchenne muscular dystrophy, and entrectinib (Genentech's Rozlytrek) for ROS1-positive metastatic non-small cell lung cancer and for other cancers with NTRK gene fusions. Additionally, FDA approved a new gene therapy onasemnogene abeparvovec-xioi (AveXis/Novartis' Zolgensma) for spinal muscular atrophy.
These approvals, PMC says, continues a trend that began in 2014 of at least 20 percent of new approved drugs being personalized therapies. "[This report] reminds us that personalized medicine offers new hope to patients with devastating diseases as well as opportunities to avoid prescribing therapies that will be unsafe or ineffective for certain populations of patients," Edward Abrahams, the president of PMC, says in a statement.
GenomeWeb earlier this year similarly noted that personalized medicine continued to grow in 2019. But it also wondered whether these new treatment approaches were reaching patients, as an analysis by the diagnostics data analytics company Diaceutics indicated that inefficiencies in the diagnostic market and limited physician education might be affecting their use.