Questioning the Need for High Doses
For cancer patients, enduring harsh side effects from powerful drugs has long been a trade-off for extended life. However, patients and doctors are now challenging the necessity of such suffering and advocating for radical changes in testing new cancer drugs.
Shifting Focus from Maximum Tolerated Dose
Unlike other diseases, cancer drug development has primarily focused on determining the “maximum tolerated dose.” While this approach has been effective for chemotherapy, newer cancer drugs that are more targeted may not require high doses to be effective.
Advocating for Lower Doses
The FDA is urging drugmakers to explore lower doses early in the research process to minimize unnecessary harmful effects of treatment. Patients like Jill Feldman, who has lived with lung cancer for 15 years, are advocating for studying lower doses to improve quality of life.
Project Optimus: A New Approach
Through Project Optimus, the FDA is pushing for more inclusive dose-finding trials to gather better data on the effectiveness of lower doses. This initiative aims to address the growing demand from patients and advocates for more tolerable cancer drugs.
Balancing Effectiveness and Side Effects
While adjusting doses may require more time and patients, experts believe that finding the right dose early in drug development will ultimately lead to more effective treatments. Patients like Lesley Kailani Glenn emphasize the importance of maintaining quality of life while undergoing treatment.
“If the patients are not taking the drug, then it’s not going to work.” – Dr. Timothy Yap