R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA
In a recently published paper in the Journal of Clinical Oncology,1 R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, of Emory University, Atlanta, and coleagues reflected on the growth in availability of oral anticancer therapies over the past decade and noted that as these treatments are easy to take at home, patients have benefited from fewer appointments as well as less travel time for checkups. However, because oral cancer therapies are self-administered in unsupervised settings, challenges in adherence to the prescribed treatment regimen can arise. Common barriers include side effects of treatments, having to take many tablets, complex treatment regimens, out-of-pocket costs, and more. Drawing on information and ideas discussed at a workshop cosponsored by ASCO and the U.S. Food and Drug Administration (FDA) in 2021, the authors described the importance of treatment adherence in cancer care and present an action plan for improvement that focuses on five key areas:
- Pharmaceutical companies and regulators should consider adherence early and throughout drug development.
- Pharmaceutical companies and regulators should expand efforts to characterize toxicity and tolerability.
- Pharmacists should assume a primary role in the care realm in supporting oral anticancer agent adherence.
- Cancer organizations should advocate for policies that ensure the affordability of oral anticancer drugs.
- Research funders should support more studies on oral anticancer agent adherence.
Workshop to Address Dose Optimization: A Key Barrier to Oral Adherence
The FDA and ASCO are holding a free virtual workshop in May 2022 on the topic of dose optimization, a critical issue in oncology given that it is a main barrier to oral medication adherence. In early-phase studies, the focus is usually on identifying the maximum tolerated dose, and little effort is often spent on identifying the optimal dose throughout drug development. Drugs are approved with recommended starting doses based on limited clinical research. Cancer drugs frequently cause toxicity that can impact quality of life and in rare cases lead to emergency care, hospitalization, and subsequent dose reduction and delay in treatment. This timely workshop will bring together thought leaders and others from academia, industry, regulatory agencies, and patient groups to discuss challenges and opportunities to improve dose selection for patients.
The workshop, called “Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology: An ASCO-FDA Workshop,” will take place on May 3 and May 5, 2022, from 1:00 PM to 4:45 PM ET each day. For more information, visit https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/getting-dose-right-optimizing-dose-selection-strategies-oncology-fda-asco-virtual-workshop-05032022.
Reference
1. Levit LA, Arora S, Kluetz PG, et al: Call to action for improving oral anticancer agent adherence. J Clin Oncol (early release online), January 6, 2022.
