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

New Indication for Somatuline Depot

Ipsen package insert; 2017 Sep

Publish date:: October 3, 2017

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-Prescribing-Information.pdf. Accessed October 1, 2017.

This Week's Must Reads

Phase II Trial of DNA Vaccine Encoding PAP in Patients with PCa ,

Utilization of Surgery for Post-prostatectomy Incontinence,

Claims Analysis of Advanced PCa Treatment Costs and Resource Use,

Testosterone Therapy Doesn't Increase Prostate Cancer Risk,

Clinical Outcomes in Cyclin-dependent Kinase 12 Mutant Advanced PCa,

Must Reads in FDA Actions

Stereotactic Radiotherapy System Approved For BC, FDA news release; 2017 Dec 22

Perjeta Approved for Certain Type of Early BC, Genentech news release; 2017 Dec 20

Bosulif Approved to Treat Newly-Diagnosed Ph+ CML, Avillion news release; 2017 Dec 19

FDA Approves Nucala to Treat Vasculitis, FDA news release; 2017 Dec 12

FDA Approves Hemlibra to Prevent Bleeding, FDA news release; 2017 Nov 9