Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

New Indication for Somatuline Depot

Ipsen package insert; 2017 Sep

The FDA has approved Somatuline Depot (lanreotide) injection 120 mg for the treatment of carcinoid syndrome.

Indications: Somatuline Depot is a somatostatin analog indicated for the treatment of adults with carcinoid syndrome; it reduces the frequency of short-acting somatostatin analogue rescue therapy.

Dosage and administration: 120 mg every 4 weeks. Do not administer an additional dose if patients are already using it for gastroenteropancreatic neuroendocrine tumors.

Efficacy and safety: Approval is based on results showing patients receiving the medication experienced 15% fewer days on rescue medication compared to patients taking placebo.

Side effects/risks: The most common adverse reactions are headache, dizziness and muscle spasm.

Citation:

Somatuline Depot [package insert]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc. 2017. http://net.somatulinedepot.com/Static/PDF/Somatuline-Depot-Full-Prescrib.... Accessed October 1, 2017.

This Week's Must Reads

Cochrane on Bisphosphonates for Breast Cancer, Cochrane; 2017 Oct 30; O'Carrigan, Wong, et al

Fiber Intake and Survival After CRC Diagnosis, JAMA Oncol; ePub 2017 Nov 2; Song, Wu, et al

Selecting Patients with Advanced NSCLC for Chemo, JAMA Oncol; ePub 2017 Nov 1; Shen, Chang, et al

Predicting CV Risk in Childhood Cancer Survivors, J Clin Oncol; ePub 2017 Nov 2; Chow, Chen, et al

CD8+ Tumor-Infiltrating Lymphocytes and Ovarian Ca, JAMA Oncol; ePub 2017 Oct 12; OTTA Consortium

Must Reads in FDA Actions

Varubi Approved for Delayed Nausea and Vomiting, Tesaro news release; 2017 Oct 25

FDA Approves Keytruda for Advanced Gastric Ca, Merck news release; 2017 Sep 22

FDA Approves Opdivo for Hepatocellular Carcinoma, Bristol-Myers Squibb news release; 2017 Sep 22

New Indication for Somatuline Depot, Ipsen package insert; 2017 Sep

Verzenio Approved for Certain Breast Cancers, FDA news release; 2017 Sep 28