At the end of May, just prior to the annual meeting of ASCO, the US Food and Drug Administration (FDA) granted fast track designation to an investigational agent called ARV-110 for treatment of metastatic, castration-resistant prostate cancer (mCRPC). This means that the drug will be moved rapidly through FDA evaluation as relevant data become available. It does not mean that the drug will necessarily be approved. It will still have to show that it is safe and effective in appropriate clinical trials, but if it does seem to be safe and effective, FDA review will be carried out on a fast timeline.
ARV-110 is being developed by a company called Arvinas, based in Connecticut. It works very differently to other available drugs for the treatment of mCRPC — apparently by degrading (i.e., breaking down) the androgen receptor protein that is essential to prostate cancer progression. You can get more details here. Information about the fast track designation is also available here on the company’s web site.
The product has only recently started to enroll patients into a Phase I trial so it will be while before we can tell just how effective and safe the drug may actually be.
Filed under: Drugs in development | Tagged: ARV-110, castration-resistant, fast, FDA, mCRPC, metastatic, track |
THE "NEW" PROSTATE CANCER INFOLINK 
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