Improving Oral Anticancer Therapy Adherence, a Call to Action & an Upcoming FDA-ASCO Workshop

March 15, 2022

In a recently published paper in the Journal of Clinical Oncology, Levit et al reflect on the growth in availability of oral anticancer therapies over the last decade and note that as these treatments are easy to take at home, patients have benefitted from fewer appointments as well as less travel time to check ups. 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 the U.S. Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) in 2021, the authors describe the importance of treatment adherence in cancer care and present an action plan for improvement that focuses on five key areas:

  1. Pharmaceutical companies and regulators should consider adherence early and throughout drug development
  2. Pharmaceutical companies and regulators should expand efforts to characterize toxicity and tolerability
  3. Pharmacists should assume a primary role in the care ream in supporting oral anticancer agent adherence
  4. Cancer organizations should advocate for policies that ensure the affordability of oral anticancer drugs
  5. Research funders should support more studies on oral anticancer agent adherence

Workshop to Address Dose Optimization, a Key Barrier to Oral Adherence

FDA and ASCO are holding a free virtual workshop in May 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 max tolerated dose, and little effort is 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.

Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology an FDA-ASCO Workshop

Dates: May 3 and 5, 2022 (1 PM – 4:45 PM ET each day)

Learn more and register to attend