Experts expressed concern that the accelerated pathway for cancer drug approval may be overused and does not always effectively balance access and efficacy.
Accelerated approvals for cancer drugs is a good idea in theory. This US Food and Drug Administration pathway allows promising new cancer agents to reach the market, and patients, sooner.The bargain the FDA has struck with manufacturers is companies can use less robust metrics — surrogate markers — to get their drugs to market earlier.
When Gyawali and colleagues published findings from a similar analysis 5 years earlier, he reported worse outcomes in confirmatory trials., which explored 93 cancer drug indications that received accelerated approval from December 1992 through the end of May 2017, revealed that only 20% demonstrated improvements in overall survival in follow-up confirmatory analyses.
Accelerated approvals often use progression-free or disease-free survival as surrogate endpoints. Progression-free survival is a common surrogate endpoint for overall survival in cancer drug trials, and one of the more reasonable surrogates, noted Liu, of Brigham and Women's Hospital and Harvard Medical School, Boston.
"That's even more problematic from our perspective because the response rate doesn't measure toxicity," Liu continued."If you give a cancer drug to a patient with cancer and it poisons the cancer, but it is also poisoning the patient, you might be inducing tumor shrinkage, but it might not be at a cost that a patient would be willing to bear."
Toxicity Poisoning Toxins Cancer Malignant Neoplasia Carcinoma Malignant Neoplasm Palliative Care Acute Pain Cancer Pain Pain From Cancer Cancer-Related Pain Tumor Hematology Haematology Hospitals Quality Of Life QOL Health Related Quality Of Life Health-Related Quality Of Life HRQOL Blood Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial
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