Lanreotide injection, a generic formulation referencing lanreotide, was approved by the FDA for GEP-NETs management.
The FDA has approved and granted competitive generic therapy designation to lanreotide injection at 120 mg/0.5 mL in a single-dose prefilled syringe, a generic formulation referencing lanreotide (Somatuline Depot), for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).¹
Lanreotide injection is indicated for adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic GEP-NETs to improve progression-free survival (PFS).² The agent is a somatostatin analog administered by deep subcutaneous injection.
The generic formulation was also FDA approved for the treatment of patients with acromegaly and carcinoid syndrome.1
“The approval and launch of lanreotide adds another material growth driver to our Affordable Medicines business,” Srinivas Kone, PhD, senior vice president and chief scientific officer of Affordable Medicines at Amneal, stated in a news release. “Lanreotide is a significant addition to our expanding complex injectables portfolio and reflects the strength of our integrated development and manufacturing capabilities. With dedicated, large-scale in-house manufacturing capacity, we are well positioned to reliably supply the market [and] broaden access to this important medicine.”
Lanreotide is a synthetic cyclical octapeptide analog of somatostatin that binds with high affinity to human somatostatin receptors 2 and 5.² Through activity at these receptors, the agent inhibits a range of endocrine, neuroendocrine, exocrine, and paracrine functions. For patients with GEP-NETs, the recommended dosage is 120 mg administered by deep subcutaneous injection into the superior external quadrant of the buttock every 4 weeks.
Lanreotide Injection in GEP-NETs: Key Prescribing Information
The lanreotide injection prescribing information notes that, in patients with GEP-NETs treated with the agent at 120 mg every 4 weeks, steady-state concentrations were reached after 4 to 5 injections. If patients are already being treated with lanreotide injection for GEP-NETs, an additional dose should not be administered for carcinoid syndrome.
The efficacy of lanreotide injection in patients with GEP-NETs was established in the multicenter, randomized, double-blind, placebo-controlled phase 3 CLARINET trial (NCT00353496) of 204 patients with unresectable, well- or moderately differentiated, metastatic or locally advanced GEP-NETs; patients were required to have nonfunctioning tumors without hormone-related symptoms. Patients were randomly assigned 1:1 to receive lanreotide injection at 120 mg (n = 101) or placebo (n = 103) every 4 weeks until disease progression, unacceptable toxicity, or a maximum of 96 weeks of treatment. The major efficacy outcome measure was PFS, defined as time to disease progression by central independent radiological review per RECIST 1.0 criteria or death.
Patients treated with lanreotide injection experienced a statistically significant improvement in PFS vs those who received placebo. Disease progression or death occurred in 31.7% of patients in the lanreotide injection arm vs 58.3% of those in the placebo arm, (HR, 0.47; 95% CI, 0.30-0.73; log-rank P < .001); the median PFS was not reached (NR; 95% CI, NR-NR) in the lanreotide injection arm vs 16.6 months (95% CI, 11.2-22.1) with placebo. The median patient age was 63 years (range, 30-92), 95% of patients were White, and 45% of patients had primary sites of disease in the pancreas, with the remainder of primary disease originating in the midgut (35%), hindgut (7%), or an unknown primary location (13%); 69% of patients had grade 1 tumors.
In the CLARINET trial, the most common adverse effects (AEs) occurring in at least 5% of lanreotide injection–treated patients and more frequently than with placebo were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reactions (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%). The rate of discontinuation due to treatment-emergent AEs was 5% in the lanreotide injection arm vs 3% in the placebo arm.
The lanreotide injection prescribing information includes warnings and precautions for cholelithiasis and its complications; hyperglycemia and hypoglycemia; cardiovascular abnormalities, such as decreased heart rate; thyroid function abnormalities; and steatorrhea and malabsorption of dietary fats. Because the agent may reduce gallbladder motility and lead to gallstone formation, periodic monitoring may be warranted, and glucose monitoring is recommended with adjustment of antidiabetic treatment as needed.
