What is Sunitinib (Sutent)?
Manufactured by Pfizer, this is a targeted biological therapy or more accurately, a multitargeted tyrosine kinase inhibitor (TKI). You may also see it described as an anti-angiogenic agent on the basis that these tumor types are highly vascularized and show high expression of something called vascular endothelial growth factor (VEGF), a key driver of angiogenesis in neuroendocrine tumors. Because NETs are generally hypervascularized tumors, treatment with antiangiogenic drugs seems a rational approach. A complex process but in the simplest of terms, sunitinib blocks a particular enzyme and keeps tumors from making their own blood vessels, which are needed to deliver oxygen and other nutrients to help them survive and grow. In clinical trials, SUTENT was shown to help slow the spread of cancer. SUTENT may also help shrink some tumors. SUTENT is not a cure, may not work the same way in every person, and not all patients will experience the same results. The drug is only approved for Pancreatic Neuroendocrine Tumours but also approved in certain scenarios for Kidney Cancer and Gastrointestinal Stromal Tumours (GIST).
The drug is administered in oral form (capsule). The recommended dose for SUTENT® (sunitinib) for pancreatic NETs is one 37.5 mg tablet once daily. It’s also available in 12.5 mg, 25 mg, 37.5 mg and 50 mg sizes.
Technical Information for Sunitinib (Sutent)?
Read more on the manufacturer’s website – click here. Specifically:
Important safety information and side effects for Pancreatic NETs – click here.
The clinical trial (SUN 1111) which led to the pancreatic NET approval can be found here.
Who can get Sunitinib (Sutent)?
The USA Food and Drug Administration approved sunitinib malate capsules (Sutent®; Pfizer, Inc., New York) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable locally advanced or metastatic disease.
Europe Medicines Agency (EMA) Approved SUTENT® (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNETs) with disease progression in adults.
UK‘s drug approval NICE states that recommended, within their marketing authorisations, as options for treating well- or (sic) moderately differentiated unresectable or metastatic neuroendocrine tumours (NETs) of pancreatic origin in adults with progressive disease
* moderately differentiated is not a term included in the World Health Organisation classification system for Neuroendocrine Neoplasms – read more about this here.
Other countries as per their own marketing authorisations and approvals.
Are there any extant clinical trials for Sunitinib?
Due to the vagaries of the Clinical Trials database, the filtering isn’t perfect. However, I carefully selected a two trials of interest both from France:
1. First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (FIRSTMAPPP). Click here. SEE 2021 UPDATE OF THIS TRIAL BELOW.
2. Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-Differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II (OCCLURANDOM). Click here.
Are there any patient support programmes for Sunitinib?
Where applicable, yes – click here.
Sunitinib remains a tool in the pancreatic NET treatment arsenal. Read a technical summary of Sunitinib (Sutent) – click here.
Read about other targeted therapies for NETs:
1. Everolimus (Afinitor) – click here.
2. Surufatinib for Neuroendocrine Cancer (SANET) – Still in clinical trial but is close to approval. Read here
Disclaimer. Ronny Allan has received no financial payment from Pzifer for producing this post and the content does not constitute a recommendation to use any of their products.
Results from the FIRSTMAPPP study presented at ESMO provide the highest level of evidence ever achieved for the benefit of sunitinib in patients with malignant progressive phaeochromocytoma and paraganglioma (MPP) (Abstract 567O_PR). This is the first academic, randomised, double-blind trial investigating the tyrosine kinase inhibitor (TKI) sunitinib in patients with these very rare cancers. In patients receiving sunitinib, the 12-month progression-free survival (PFS) rate – the primary endpoint of the study – was 35.9%, meeting the prespecified target increase from 20% to 40%. The 12-month PFS rate with placebo was 18.9%. Of the 78 patients recruited over a period of 8 years, 60% had received prior therapy. “This is a strong result for a treatment based on sound mechanistic principles,” says Prof. Juan Valle, University of Manchester and Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Read more at the link below.
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.
Inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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