US FDA Approval of Afinitor Ends a Three Decade Long Wait for Pancreatic Neuroendocrine Tumor (PNET) Patients by GlobalData

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									            US FDA Approval of Afinitor Ends a Three Decade Long Wait
               for Pancreatic Neuroendocrine Tumor (PNET) Patients
        Reference Code: GDHC0034VPT                                                                                                      Publication Date: May 2011


        1         Table of Contents                                                              2       Summary
        1 Table of Contents............................................................. 1       On May 5, 2011, the US Food and Drug Association (FDA)
        2 Summary ......................................................................... 1    approved Afinitor (everolimus) for the treatment of progressive
        3 Neuroendocrine Tumors Overview.................................... 2                   neuroendocrine tumors of pancreatic origin (PNET) in patients
         3.1 Disease Overview ...................................................... 2           with unresectable, locally advanced or metastatic disease. It
           3.1.1    Types of Neuroendocrine Tumors ...................... 2                      has become the first drug to be approved for the indication in
         3.2 Epidemiology ............................................................. 2
                                                                                                 nearly 30 years. The approval has been particularly important
         3.3 Diagnosis................................................................... 2
         3.4 Current Therapy Options ............................................ 3              as there are no therapies currently available that can
         3.5 Unmet Need .............................................................. 3         significantly delay tumor growth and improve the progression-
         3.6 Drivers and Barriers ................................................... 3          free survival of patients with advanced PNET, and as a result
           3.6.1    Drivers .............................................................. 3     this drug has been eagerly anticipated. With a novel
           3.6.2    Barriers............................................................. 3      mechanism of action and demonstrated efficacy in extending
         3.7 Afinitor – New Therapy for Advanced Pancreatic
                                                                                                 progression-free survival, Afinitor should invigorate a stagnant
              Neuroendocrine Tumors............................................. 4
           3.7.1    Clinical Trial Details........................................... 4          and underserved market. The only other FDA approved drug for
         3.8 Dosage and Pricing of Afinitor .................................... 4               the treatment of PNET is Sandostatin LAR (ocreotide acetate),
         3.9 Neuroendocrine Tumors Market ................................. 4                    which specifically treats GI carcinoid tumors. Afinitor approval
        4 Appendix.......................................................................... 4   paves the way for other PNET drugs in the pipeline, such as the
         4.1 Methodology .............................................................. 4        promising candidate Sutent (sunitinib), which is already
           4.1.1    Coverage .......................................................... 4        approved by the European Medicines Agency for this indication.
           4.1.2    Secondary Research ......................................... 5
           4.1.3    Primary Research.............................................. 5             Afinitor targets mammalian target of rapamycin (mTOR), and
           4.1.4    Expert Panel Validation ..................................... 5              inhibits the action of this serine protein kinase that stimulates
         4.2 Contact Us................................................................. 5       cell growth and proliferation leading to reduced tumor cell
         4.3 Disclaimer.................................................................. 5
                                                                                                 growth, decreased tumor angiogenesis, thus, inhibition of cell
                                                                                                 metabolism. Pancreatic NETs generally proliferate by the
                                                                                                 autocrine activation of the mTOR signaling pathway, mediated
                                                                                                 through insulin-like growth factor. Consistent with this
                                                                                                 observation is the finding that inhibition of mTOR has a
                                                                                                 significant antiproliferative effect on pancreatic neuroendocrine
                                                                                                 tumor cell lines.
                                                                                                 Afinitor was developed by Novartis, a multinational
                                                                                                 pharmaceutical company, which provides healthcare solutions
                                                                                                 that address the evolving needs of patients and societies.
                                                                                                 Currently, the advanced PNET therapeutics market has high
                                                                                                 unmet need, with only two approved options available to
                                                                                                 patients, in the form of Sandostatin LAR (ocreotide acetate) and
                                                                                                 Sutent (sunitinib). None of these are proven to extend the
                                                                                                 progression-free survival rate for patients, and the efficacy of
                                                                                                 these marketed products is moderate in terms of offering longer
                                                                                                 life expectancy and delayed tumor growth.




                                                                                                                                                   Market Analysis Alert
US FDA Approval of Afinitor Ends a Three Decade Long Wait for                                                                            GDHC0034VPT /MAY 2011/ Page 1
Pancreatic Neuroendocrine Tumor (PNET) Patients
                                                                                   
								
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