FDA panel vote puts Geron’s imetelstat on brink of approval

A US Food and Drug Administration (FDA) advisory panel has voted in favor of the clinical benefit/risk profile of imetelstat for transfusion-dependent (TD) anemia in adults with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).

The vote by 12 to two members of the Oncologic Drugs Advisory Committee (ODAC) led to shares in Geron Corporation (Nasdaq: GERN) - which is developing the investigational first-in-class telomerase inhibitor to treat hematologic malignancies - to leap by 87% during Thursday’s trading.

"There are few treatment options and significant unmet medical need remains for these patients"The committee had reviewed the results from the IMerge Phase III trial, which met its primary endpoint.