The U.S. Food and Drug Administration (FDA) has advised drugmakers to find the lowest effective dose of new cancer treatments, even if it takes longer. Treatment advances have extended the lives of millions with incurable cancers. Newer cancer medications are more focused and operate differently, making it hard to pinpoint the “sweet spot” for dose reduction.
Living longer has come with unpleasant side effects from powerful drugs, but patients and physicians are wondering if it’s worth it. This has sparked a drive to drastically change how new cancer treatments are tested, with the FDA urging drugmakers to discover the lowest effective dose even if it takes longer. Millions of incurable cancer patients survive for years thanks to medical advances. Because to such development, Jill Feldman, 54, of Deerfield, Illinois, has lived 15 years with lung cancer. Her cancer treatment produces weariness, mouth sores, and joint pain that makes eating and drinking unpleasant.
Cancer therapy development has concentrated on the “maximum tolerated dose.” Early trials increase dosage in a few persons to determine the maximum tolerated dose of chemotherapeutic medications to hasten testing. The “more is better” mentality works for chemotherapy but not for newer cancer treatments like Feldman’s.
New cancer medications target a mutation that causes cancer cell proliferation or change the immune system to attack it. Toronto Princess Margaret Cancer Center drug development chief Dr. Lillian Siu says “you might only need a low dose to turn off that cancer driver.” Through Project Optimus, the FDA encourages drugmakers to include more patients in early dose-finding trials. The initiative was driven by “the growing calls from patients and advocates that cancer drugs be more tolerable,” said FDA spokesperson Chanapa Tantibanchachai in an email.
The previous technique was used to develop many new cancer treatments, causing patients to skip doses or quit taking them due to negative effects. Some doses were dropped after approval, whereas others were lowered one patient at a time. One study found that nearly half of late-stage trials of 28 targeted therapy medicines required dose reductions.
Metastatic breast cancer patients, including the Patient Centered Dosing Initiative, have questioned excessive doses, as have cancer doctors. Dr. Alice Shaw, Novartis’ early cancer medication development leader, said adding six months to a year must be evaluated against the urgent need for new cancer treatments. If people don’t take the drug, it won’t work, thus getting the dose right early will lead to more effective drugs.
Conclusion
The US FDA has advised drugmakers to find the lowest effective dose of new cancer treatments, despite the time commitment. The FDA wants more people to participate in early dose-finding trials under Project Optimus since newer medications are more targeted and operate differently. Reducing the dose for everyone may underdose some people. A 500-patient research will explore lower doses of two breast cancer medicines.
