Oncology

SOMATULINE^® is key to Ipsen’s leadership in the treatment of neuroendocrine tumors (NETs).  NETs are neoplasms that arise from cells of the endocrine (hormonal) and nervous systems. Many are benign, while some are malignant. They most commonly occur in the intestine, where they are often called carcinoid tumors, but they are also found in the pancreas, lung and the rest of the body.

SOMATULINE^®, has been shown to reduce the risk of disease progression or death by 53%.⁸  SOMATULINE^® continues to grow because it provides a solution to an indolent disease that requires tumor and symptom control.  It is marketed in over 55 countries, 27 of them in Europe.

There are more than 250,000  new cases of renal cell carcinoma worldwide every year and Ipsen has the first and only multi-targeted therapy to prolong survival, slow disease progression and shrink tumors in patients with advanced renal cell carcinoma (RCC).  In September 2016, Ipsen and Exelixis announced positive results from the phase 2 CABOSUN trial of cabozantinib versus sunitinib in previously untreated advanced renal cell carcinoma. This treatment offers an opportunity to extend survival for patients suffering from RCC, which is responsible for nine out of ten cases of kidney cancers.

HCC is the most common form of liver cancer in adults.¹² The disease originates in cells called hepatocytes found in the liver. With approximately 800’000 new cases diagnosed each year, HCC is the sixth most common cancer and the second-leading cause of cancer deaths worldwide^13,14 . According to the GLOBOCAN data, it is estimated that across the European Union (EU-28) nearly 60’000 new patients will be diagnosed with liver cancer in 2020 ¹⁵.5 Without treatment, patients with the disease in advanced stage usually survive between 4 and 8 months.¹⁶  In November 2018, the European Commission (EC) approved CABOMETYX® (cabozantinib) 20, 40, 60 mg as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. This approval allows for the marketing of CABOMETYX® (cabozantinib) in this indication in all 28 member states of the European Union, Norway and Iceland. The EC approval is based on the results of the global placebo-controlled CELESTIAL phase 3 pivotal trial which met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared with placebo in patients with advanced HCC who have been previously treated with sorafenib. ¹⁷

In 2017, we took a strategic step forward in strengthening our oncology portfolio by securing the commercialization of ONIVYDE^® in the US, a landmark FDA approved treatment for metastatic pancreatic cancer.  

Prostate cancer is the 2^nd most common type of cancer in men.¹¹  DECAPEPTYL^® (triptorelin) continues to grow in this area, with Ipsen the leader in Spain and Belgium. DECAPEPTYL^® is a synthetic hormone therapy primarily indicated for the hormonal treatment of locally advanced metastatic prostate cancer, that can be now injected subcutaneously too.

In March 2017, the MHRA in the UK, in coordination with 14 other European regulatory agencies, approved a new indication for DECAPEPTYL^® as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, for women at high-risk of breast cancer recurrence.  The indication is launched in six countries and submission for approval is underway in three other countries/regions, with launches expected in more than 15 European countries.

HEXVIX^® (hexaminolevulinate), is a photosensitizing agent that improves detection and resection of non-invasive bladder cancer and is a significant improvement for urologists and their patients.

XERMELO is for the treatment of carcinoid syndrome diarrhea in patients whose symptoms are not adequately controlled with somatostatin analogue therapy (SSA). Carcinoid syndrome occurs in about 20% of all neuroendocrine tumors.   Effective treatments to improve the health and lives of patients, whose carcinoid syndrome is not adequately controlled with SSA therapy, are needed.

Medullary Thyroid Cancer accounts for 5% of thyroid cancers. Novel treatment options are needed for progressive MTC. COMETRIQ^® has been proven to make a significant difference in the duration of progression-free survival versus placebo.

1. Pollock PA et al. Current Oncology – Volume 22, Number 1, February 2015
2. American Cancer Society. What Are the Key statistics About  Kidney Cancer? 2017
3. Ferlay J, Soerjomataram I, Dikshit R, et al: Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136:E359-86, 2015
4. GLOBOCAN International Agency for Research on Cancer (IARC). Available at: http://gco.iarc.fr/today/factsheets-cancers?cancer=7&type=0&sex=0
5. American Cancer Society: Cancer Facts & Figures 2018
6. Globocan 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. (Accessed 27 July 2017, found here
7. Medullary Thyroid Cancer Search: Encyclopédie Orphanet (accessed on July 2017 at found here
8. Van der Zwan J., EJC (2013) 49, 2565-2578
9. Cadarella A., Pathol Oncol Res. 2013.
10. Results of the CLARINET Study
11. Pollock PA et al. Current Oncology – Volume 22, Number 1, February 2015
12. McGlynn KA, London WT. The Global Epidemiology of Hepatocellular Carcinoma, Present and Future. Clinics in liver disease. 2011;15(2):223-x. doi:10.1016/j.cld.2011.03.006.
13. Ferlay J, Soerjomataram I, Dikshit R, et al: Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 136:E359-86, 2015
14. GLOBOCAN International Agency for Research on Cancer (IARC). Available at: http://gco.iarc.fr/today/factsheets-cancers?cancer=7&type=0&sex=0
15. GLOBOCAN International Agency for Research on Cancer (IARC). Available at: http://globocan.iarc.fr/Pages/burden_sel.aspx
16. Annals of Oncology 23 (Supplement 7): vii41–vii48, 2012
17. Abou-Alfa GK et al. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63.