New Approach Urged by Patients and Doctors
For cancer patients, the **harsh side effects** of potent drugs have long been a necessary evil in exchange for extended life. However, a new movement is challenging this status quo, advocating for a **radical shift** in how new cancer drugs are tested. The U.S. Food and Drug Administration is pushing for drugmakers to prioritize finding the **lowest effective dose**, even if it means a longer testing process.
Personal Stories Drive Change
Jill Feldman, a long-term lung cancer survivor, highlights the **suffering** caused by her cancer drug’s side effects. Despite living for 15 years with cancer, she endures **joint pain**, **fatigue**, and **mouth sores** that make daily activities like eating and drinking excruciating. Feldman’s plea for drugmakers to investigate lower doses early in the research phase resonates with many patients who believe that unnecessary suffering should be avoided.
Shifting Focus in Drug Development
Traditionally, cancer drug development has revolved around identifying the **maximum tolerated dose**, a strategy that works well for chemotherapy but may not be as effective for newer, more targeted drugs. Experts suggest that a **lower dose** could be equally potent in certain cases, reducing side effects and improving quality of life for patients. The FDA’s Project Optimus aims to encourage drug developers to explore **lower dosages** in early trials to gather more comprehensive data on their efficacy.
Balancing Act for Effective Treatment
While adjusting drug dosages early in the development process may prolong timelines, experts argue that getting the dose right from the start will ultimately lead to **more effective** drugs. Patient advocates like Lesley Kailani Glenn emphasize the importance of **maintaining quality of life** during treatment, urging for a more **patient-centered** approach in cancer drug development. By prioritizing tolerability and efficacy, the medical community aims to **revolutionize cancer treatment** for millions of patients worldwide.
