Change is coming in cancer treatment. Last year, the U.S. Food and Drug Administration approved its first-ever engineered cell therapies for cancer, which involve genetically reprogramming patients’ T cells to aim the power of their immune systems squarely at their cancers.
Both of these new therapies are approved only for people with certain advanced cancers who have been failed by multiple conventional treatments, like chemotherapy. Some people may wonder: If these treatments are so promising, why aren’t they available for more patients, including those who have just been diagnosed?
The short answer: We are not yet sure if the benefit outweighs the risk for patients at earlier stages of disease.
If these new treatments run a course anything like many other cancer therapies, however, they may eventually move up to the frontlines of therapy.
As more trial participants receive a new therapy, researchers rack up more evidence about what’s on both sides of that critical risk-benefit balance. If the earliest clinical trials show that a new approach is safe, researchers begin to look at whether it could offer more benefit, less risk, or both compared to existing treatments. Gradually the equilibrium can move toward allowing studies in patients who are not quite yet at the end of the line, whose disease is not quite so advanced. So, for many new drugs, that means a stepwise approach: First comes approval in late-stage disease, then as new trials open for individuals with earlier-stage disease, approvals for wider ranges of patients may follow.
Read the full article about how drugs become available to more patients by Susan Keown at Fred Hutchinson Cancer Research Center.
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