FDA New Drug and Biologic Approvals, 2018 Midyear Review

Gastroenteropancreatic Neuroendocrine Tumors: Lutathera (lutetium Lu 177-dota-tate)

Indication: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Mechanism: Radiolabeled somatostatin analog. It binds to somatostatin receptors with highest affinity for subtype 2 receptors (SSRT2).

Dosage: 7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 doses administered with premedication and concomitant medications.

Approval was based on the NETTER-1 clinical trial. The trial was a single-institution, single-arm, open-label trial conducted by Erasmus Medical Center in Rotterdam, Netherlands, in more than 1,200 patients with somatostatin receptor positive tumors. Results showed a 79% reduction in risk of disease progression or death in the Lu 177 arm compared with octreotide LAR 60 mg arm (95% CI: 0.13-0.32; P<0.0001). Median PFS was not reached in the Lu 177 arm compared with 8.5 months for octreotide LAR. An interim overall survival analysis determined that Lu 177 treatment led to a 48% reduction in the estimated risk of death (hazard ratio 0.52, 95% CI: 0.32-0.84) compared with octreotide LAR.

Reference:

• Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. https://www.nejm.org/doi/full/10.1056/NEJMoa1607427

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.