Commercial

ACROMEGALY

• For the long-term treatment of individuals with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

NEUROENDOCRINE AND ADRENAL TUMORS

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

• For the treatment of unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
  

Neuroendocrine Tumors of the Gastrointestinal Tract (Well-Differentiated Grade 1/2), Lung and Thymus (Carcinoid Tumors)

• For the treatment of adult individuals with carcinoid syndrome to reduce the frequency of short-acting somatostatin analog rescue therapy.
• For the treatment of neuroendocrine tumors of the gastrointestinal tract, lung, and thymus (carcinoid tumors) for any of the following indications:
• Primary treatment for symptom and/or tumor control of ​unresected primary gastrinoma
• As primary therapy​ for symptom and/or tumor control of multiple lung nodules or tumorlets and evidence of diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH) if chronic cough/dyspnea is not responsive to inhalers or conventional treatment
• ​For symptom and/or tumor control of recurrent, locoregional advanced disease and/or distant metastases* of the gastrointestinal tract as a single agent for any of the following:
• For unresectable and a low tumor burden
• For disease progression (if not already receiving) following resection of primary + metastases
• For​ disease progression (if not already receiving) following observation for unresectable low tumor burden
• Following resection of primary tumor if unresectable and locally symptomatic from primary tumor
• As a single agent or in combination with alternative front-line therapy if unresectable and clinically significant tumor burden
• As subsequent therapy at above label dosing after clinical, symptomatic, or radiographic progression (if somatostatin receptor-positive [SSTR-positive]) on standard doses (useful in certain circumstances)
• For symptom and/or tumor control of recurrent and/or locoregional unresectable bronchopulmonary/thymic disease* if SSTR-positive and/or hormonal symptoms for one of the following regimens:
• As primary therapy
• As subsequent therapy (as alternate primary therapy) if progression on primary therapy
• For symptom and/or tumor control of recurrent and/or distant metastatic bronchopulmonary/thymic disease* if SSTR-positive and/or hormonal symptoms for one of the following regimens:​
• As primary therapy 
• As subsequent therapy (as alternate primary therapy) if progression on primary therapy ​
• For symptom and/or tumor control of recurrent and/or distant metastatic bronchopulmonary/thymic disease* if SSTR-positive and/or hormonal symptoms for one of the following regimens:
• As primary therapy (National Comprehensive Cancer Network [NCCN] preferred if clinically significant tumor burden and low grade [typical carcinoid], evidence of disease progression, intermediate grade [atypical carcinoid], or symptomatic)
• As subsequent therapy (as alternate primary therapy) if progression on primary therapy if clinically significant tumor burden and low grade (typical carcinoid), evidence of disease progression, intermediate grade (atypical carcinoid), or symptomatic (NCCN preferred)​​

• Treatment of carcinoid syndrome for any of the following regimens:
• As a single agent
• In combination with telotristat for persistent diarrhea due to poorly controlled carcinoid syndrome
• In combination with other systemic therapy options (based on disease site) with or without telotristat for persistent symptoms (i.e., flushing, diarrhea) due to poorly controlled carcinoid syndrome 

Neuroendocrine and Adrenal Tumors - Well-Differentiated Grade 3 Neuroendocrine Tumors
 

• For the treatment and/or tumor control of SSTR-positive (if SSTR-positive and/or hormonal symptoms) for unresectable locally advanced/metastatic disease with favorable biology (e.g., relatively low Ki-67 [<55%], slow growing, ​positive SSR-based PET imaging) at standard dose​

Tumors of the Pancreas (Well-Differentiated Grade 1/2)

• Management of symptoms and/or tumor control ​of locoregional disease with any of the following indications:
  
• Gastrinoma (usually duodenal or head of the pancreas)
• Glucagonoma (usually tail)
• VIPoma​ 
  
• As NCCN-preferred regimen for symptom and/or tumor control* in individuals** with recurrent or locoregional advanced disease and/or distant metastatic disease if SSTR-positive with any of the following indications:​
• As a single agent for asymptomatic, low tumor burden and stable disease
• As a single agent for symptomatic, clinically significant tumor burden, or clinically significant progression (if not already receiving)
• In combination with alternative front-line therapy for symptomatic, clinically significant tumor burden, or clinically significant progression​​
• For symptom and/or tumor control as subsequent therapy at above label dosing after clinical, symptomatic or radiographic progression on standard doses (if SSTR-positive) 

• As primary treatment for secreting tumors for hormone excess and symptom control of locally unresectable disease or distant metastases (if SSTR-positive)​