The FDA has informed Heron Therapeutics, Inc., that it has not yet completed its review of the new drug application for granisetron injection, extended release (Sustol), and would not be taking action by the Prescription Drug User Fee Act goal date of January 17, 2016. The agency now anticipates taking action in late February 2016.
Sustol is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron that is being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). Sustol is formulated using Heron’s proprietary Biochronomer drug delivery technology, and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.
Sustol was the subject of the recently completed phase 3, placebo-controlled MAGIC (Modified Absorption Granisetron In the Prevention of CINV) trial involving patients receiving HEC regimens. The study evaluated the efficacy and safety of Sustol as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone. The study’s primary endpoint was achieved. Specifically, the percentage of patients with a complete response in the delayed phase (24 to 120 hours) was significantly higher in the Sustol arm compared with the current standard of care (P = 0.014). Injection-site reactions were the most common adverse events.
Sustol was also the subject of a phase 3, randomized, observer-blind, active-controlled, double-dummy, parallel-group study that compared the efficacy of Sustol with that of palonosetron (Aloxi, Eisai) for the prevention of CINV. Palonosetron is approved for the prevention of acute and delayed CINV associated with MEC regimens and the prevention of acute CINV associated with HEC regimens. In this study, which enrolled more than 1,300 patients, Sustol successfully demonstrated efficacy that was statistically noninferior to that of palonosetron in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.