FDA Approves Newly Designed Syringe for Lanreotide in GEP-NETs

June 25, 2019

The FDA has granted an approval to a prefilled syringe for lanreotide (Somatuline Depot), which has been designed to enable healthcare providers to administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The indications for the treatment remain the same as that of the previously approved prefilled syringe, according to an announcement made by Ipsen Biopharmaceuticals, the developer of the product.

The syringe can be used as a means to improve progression-free survival (PFS) and in adult patients with carcinoid syndrome to reduce the frequency of short-acting somatostatin analog rescue therapy. The syringe is also indicated for use in the long-term treatment of patients with acromegaly who inadequately respond to surgery and/or radiotherapy as well as for those who are not candidates for surgery and/or radiotherapy.

“The conditions of GEP-NETs and acromegaly can be associated with a number of uncomfortable and unpleasant symptoms, and innovation aimed at improving the injection process is a step forward,” Daphne Adelman, a clinical nurse specialist at Northwestern University, stated in a press release.

In an effort to understand the way the syringe was being used in clinical practice as well as identify ways in which features of the device might be improved, investigators launched 5 different, but complementary, studies in partnership with patients, their caregivers, nurses, and other healthcare professionals.

The feedback from these studies informed the redesign for the syringe, which was envisioned to increase the grip on the product, and thus, make it easier to administer the injection. The new syringe also includes a needle shield removal system, a more stable plunger, and Thermoform tray which contains recessed areas that could help prevent accidental plunger depression. The built-in safety system, which had originally been designed to prevent needle stick injury by locking in place following treatment administration, has not been updated.

“We consistently look for opportunities to respond to the needs of the communities we serve, and this approval would not have been possible without the direct involvement of nurses and the patients with GEP-NETs and acromegaly whom they treat,” Bradley Bailey, SVP, franchise head of the Oncology/Endocrinology Business Unit at Ipsen, also stated in the press release. “We listened and collaborated to enhance the existing prefilled syringe, making it sturdier for healthcare providers when administering treatment, with the intention of improving the injection process.”

Lanreotide was originally approved in December 2014 for the treatment of patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs, based on data from the phase III CLARINET trial. The product was granted an approval under the FDA’s priority review program based on a significant increase seen in PFS. Specifically, treatment with the injection improved PFS by 53% versus placebo in patients with grade 1/2 GEP-NETS, according to results published in the New England Journal of Medicine.²

Additionally, quality of life was found to be comparable between those who received lanreotide and those who were given placebo. The somatostatin analog was the first of its kind to show a statistically significant improvement in PFS.

The newly approved syringe is intended for deep subcutaneous injection and should only be administered by healthcare professionals. The syringe is projected to be available for use in the third quarter of 2019. The product is approved for use in the United States and Europe as well as additional ex-US markets.

References

Ipsen Announces US FDA Approval for Newly Designed Pre-Filled Syringe Somatuline Depot (lanreotide) [press release]. Ipsen. Published June 24, 2019. http://bit.ly/2IEyy8G. Accessed June 24, 2019.
Caplin ME, Pavel M, Ćwikła JB, et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014;371(3): 224-233). doi: 10.1056/NEJMoa1316158.