Geron Corporation (GERN), a biopharmaceutical company at the commercial stage, announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of RYTELO. This recommendation is for its use in treating transfusion-dependent anemia caused by lower-risk myelodysplastic syndromes (LR-MDS), a form of blood cancer.
The favorable recommendation stems from the encouraging outcomes of the IMerge Phase 3 study, which demonstrated that patients receiving RYTELO required fewer red blood cell transfusions compared to those receiving a placebo.
The European Commission is anticipated to reach a final decision regarding the marketing authorization application in the upcoming months. Notably, the drug has already received approval from the U.S. Food and Drug Administration (FDA).
