What is the EORTC’s track record with industry?

Prospective intention to register trials

EORTC conducts registration trials, examples are:

  • Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy. FDA approval on 26 April 2012; EMA conditional marketing authorization on 14 June 2010; full marketing authorization on 1 July 2013 EORTC trials 62043, 62072
  • Sylatron (pegylated interferon α-2b) for the treatment of melanoma patients with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. FDA approval on 29 March 2011. EORTC trial 18991. Post-registration commitment, EORTC trial 180891, for patients with an ulcerated primary cutaneous melanoma.
  • Yervoy (Ipilimumab) for the treatment of patients with late stage (metastatic) melanoma. FDA approval on 28 March 2011; EMA approval on 13 July 2011. EORTC trial 18071
  • Taxotere (docetaxel) for the treatment of breast, non-small-cell lung, prostate, and head and neck cancers. EMA approval on 27 November 1995  EORTC trial 24971
  • Fludara (Fludarabine) for treatment of patients with stages III and IV low grade malignant non-Hodgkin’s lymphoma. EORTC trial 20921

Academic trials serving for drug registration

EORTC performs trials which can serve a posteriori registration purposes. Examples are:

  • Dacogen (decitabine) for the treatment of patients with myelodysplastic syndromes. FDA approval on 2 May 2006; EMA approval on 20 September 2012. EORTC trial 06011
  • Yondelis (Trabectedin) for the treatment of advanced or metastatic soft tissue sarcoma, EMA approval on 20 September 2007, and in November 2009 for the treatment of relapsed platinum-sensitive ovarian cancer in combination with DOXIL®/Caelyx®. EORTC trials 62043, 62072
  • MabThera (Rituximab) for the extension of the indication in maintenance treatment of patients with follicular lymphoma responding to induction therapy. EMA approval on 11 July 2006. EORTC trial 20981
  • Temozolomide (Temodar) for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. FDA approval on 15 March 2005. EORTC 26981
  • Glivec (Imatinib Mesylate) for the treatment of adult patients with c-Kit (CD117)–positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GISTs). FDA approval on 01 February 2002; EMA approval on 31 May 2002. EORTC trials 62001, 62005
  • Tarceva for the treatment of patients with glioblastoma multiforme. EORTC trial 26034
  • Vaccination therapy with adjuvant anti-idiotypic antibody BEC2 combined with Bacillus Calmette-Guérin (BCG) for treating patients with limited stage small cell lung cancer. EORTC trials 08971, 08971b

Trials in Development

  • Phase 3 clinical development of niraparib, a potent orally active poly ADP-ribose polymerase (PARP) inhibitor, in patients with breast cancer. EORTC trial 1307

New operational models

The EORTC promotes a partnership-model where each stakeholder in clinical research and development lends its expertise with clearly defined responsibilities and well established infrastructures.

In such model, the expertise of each partner is valued as depicted here under (from: Academia–Industry Partnerships: Are we ready for new models of partnership? The point of view of the EORTC, an academic clinical cancer research organization. Denis Lacombe, Susen Burock, Françoise Meunier. European Journal of Cancer 2013; 49(1):1-7.

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