2023 marks the 25-year anniversary of the approval of Herceptin®, which changed the diagnosis of HER2+ breast cancer from a death sentence to one of hope thanks to Herceptin’s ability to target HER2.
This monumental advancement also paved the path for future targeted drug development and approval. Fast forward to the last decade and personalized medicine has evolved from promise to reality, accounting for more than 25% of FDA approvals for the last seven years, momentum that is here to stay and is beginning to reach beyond oncology and rare diseases.
of FDA approvals for each of the last seven years
Personalized medicines accounted for more than 25% of FDA approvals for each of the last seven years
Shifting from the traditional ‘one-size-fits-all’ approach of developing and prescribing therapies has benefits not only for patients but also for clinicians, who often resort to trial and error to find the best treatment for a given patient and in clinical trials, leading to new and adaptive designs.
Trial protocols can focus on the patients most likely to respond and least likely to experience serious adverse events, contributing to faster times to market and greater success rates. Challenges yet to be overcome include regulatory harmonization, cost-effectiveness and reimbursement and the widespread infrastructure to identify eligible patients and ensure they have access to the treatments they need.