FDA adcomm votes in favor of Geron’s anemia drug for cancer patients despite questions on risk

Mem­bers of the FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee vot­ed 12 to 2 on Thurs­day that the ben­e­fits of Geron’s ime­tel­stat out­weigh safe­ty risks for the treat­ment of cer­tain ane­mic myelodys­plas­tic syn­drome (MDS) pa­tients who are de­pen­dent on blood trans­fu­sions.

While reg­u­la­tors raised con­cerns around cas­es of cy­tope­nia, or low lev­els of white blood cells or platelets, ad­vi­so­ry com­mit­tee mem­bers said they were con­fi­dent that the risks ap­pear man­age­able. The FDA not­ed on Thurs­day that there was a “no­tably high­er” in­ci­dence of neu­trope­nia and throm­bo­cy­tope­nia in the ime­tel­stat arm of a Phase III tri­al.

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