The Committee will discuss new drug application (NDA) 217779 for Imetelstat for injection, submitted by Geron Corporation. The proposed indication for this product is for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents.
Meeting Information and Materials: [ Ссылка ]

свернуть