Developing a new cancer drug is a complex and multi-step process that requires extensive preclinical and clinical testing before approval by the US Food and Drug Administration (FDA). Here are the general steps involved in getting a cancer drug through FDA approval:
Preclinical Testing: In the preclinical testing stage, the drug is tested in laboratory settings and animal models to determine its safety, efficacy, and potential toxicities.
Investigational New Drug (IND) Application: After preclinical testing, the drug developer files an IND application with the FDA, providing all the data obtained during preclinical testing.
Phase I Clinical Trials: Phase I clinical trials involve testing the drug in a small group of healthy volunteers or patients to determine the safe dose range and any potential side effects.
Phase II Clinical Trials: In this phase, the drug is tested in a larger group of patients to evaluate its efficacy and to identify any potential side effects.
Phase III Clinical Trials: In Phase III trials, the drug is tested in a much larger group of patients to confirm its safety and efficacy compared to existing standard treatments.
New Drug Application (NDA): After successful completion of Phase III clinical trials, the drug developer submits a New Drug Application (NDA) to the FDA, which includes all the data collected during preclinical and clinical trials.
FDA Review: The FDA reviews the NDA, and if the drug meets safety and efficacy standards, the FDA approves the drug for use.
Post-Approval Monitoring: Once the drug is approved, the FDA continues to monitor its safety and efficacy in real-world settings, and the drug developer is required to submit periodic reports to the FDA.
It is important to note that the process of getting a cancer drug through FDA approval can take many years and cost billions of dollars. The success rate of drug development is relatively low, with only a small fraction of drugs making it through all the stages of development and approval.
Doctor Robert Imani has extensive years of experience in this area.
