GERN - FDA Approves Geron's First Commercial Drug Competes With Bristol Myers Squibb's Blood Cancer Drug | Benzinga
On Thursday, the FDA approved Geron Corporation's (NASDAQ:GERN) Rytelo (imetelstat) for adult patients with low-to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia.
The approval covers patients requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
In March, by a 12-to-2 margin, the FDA adcomm panel voted in favor of the benefits of imetelstat, stating that the associated risks and toxicities of the treatment appear to ...