In case you missed it, Boston Healthcare Associates recently published a report examining how additional benefits of cancer medicines emerge over time through ongoing research after initial approval from the FDA.
To discuss the report and what it means for patient care, Tom Goss, one of the lead authors of the report, participated in a Q&A with BioSpace News.
A few highlights:
- The value of a medicine continues to emerge over time: “[T]he full therapeutic value of a cancer therapy is typically realized long after the drug’s initial FDA approval… improvement in patient outcomes is generally observed over time, through an incremental process as experience is gained with new treatments and interventions, and longer term survival and other longer-term endpoints are examined.”
- Continuing research post-approval reveals previously unknown benefits: “In oncology in particular, new therapies may undergo an accelerated approval pathway where determination of efficacy is based on surrogate or intermediate endpoints. Through ongoing study, after the medicine has been approved, additional survival and disease response benefits are often revealed that were not able to be assessed at the time of that initial approval.”
- Additional benefits are recognized through a number of different pathways: “Emerging advances in personalized medicine are driving increased utilization of diagnostic tests, for example, which may direct more precise treatment choices. Increasing understanding of the underlying biology of the disease is also revealing that many cancer medicines are useful in other types of cancers besides the one they were originally approved to treat.”
Check out the full report here.
Emma Van Hook Emma Van Hook is a director of Policy & Research at PhRMA focusing on the promise of the biopharmaceutical pipeline, the value of medicines, the R&D process, and personalized medicine. Emma is a biology nerd at heart and has worked in both bench science and in regulatory affairs, helping to get new medicines through the development and FDA approval processes. In her free time, Emma likes to get outside the Beltway for running and hiking with her family and her dog Blue.