Fast track new drug trial

FDA Places PC14586, for Cancers with Mutant Protein, on Fast Track

https://tinyurl.com/y5kv3utz

 

         Of recent times there has been a concentration on the treatment of ovarian cancer resulting from inherited or germ line mutations. High Grade Serous Ovarian Cancer is the commonest and most lethal, this is associated with an acquired or somatic mutation (TP53) in about 97% of cases.

          Now for the first time, a recent determination, by the Federal Drug Agency to fast-track acceptance for investigation of a new drug; PC14586, raises the prospect of a remedy for this somatic mutation.

         This drug is to be tested through a Phase I/II trial looking to establish its safety and effectiveness.   As with all clinical trials, the likelihood of progression to standard treatment is less than 2%.