Treatment of metastatic and/or unresectable GIST: Bayer has submitted a “New Drug Application (NDA)” to the FDA for Regorafenib.
End of August 2012, Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its oral multi-kinase inhibitor Regorafenib for the treatment of metastatic and/or unresectable GIST (Gastrointestinal Stromal Tumours) in patients whose disease has progressed despite prior treatment with other kinase inhibitors. Usually these prior therapy options are Imatinib (Glivec®) as a first-line-treatment and Sunitinib (Sutent®) as a second-line-treatment.
European Commission grants marketing authorisation for Pazopanib (Votrient®) in the treatment of certain advanced soft tissue sarcoma subtypes
GlaxoSmithKline (GSK) announced on the 7th of August 2012 that the European Commission has granted Pazopanib marketing authorisation for the treatment of patients with advanced soft tissue sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.
SPAEN is delighted to provide a comprehensive report of the ASCO 2012 medical highlights in GIST and Sarcomas from Dr Axel Le Cesne, Gustave Roussy Institute, Villejuif (France). Sarcomas and GIST were presented at 5 plenary and parallel sessions. These were rich in terms of innovation and therapeutic concepts, reporting study results that may have an impact on our daily practice, whether in GIST or sarcomas.
Conducting clinical trials in people with rare cancers (incl. Sarcomas) is not easy when the number in a small trial do not add up to convincing evidence. Now some researchers are pressing for a new approach - using Bayesian trial designs to make the most of available knowledge. Read more at Cancer World.
Phase III Data on Regorafenib Met Primary Endpoint Showing Significant Improvement in Progression-Free Survival (PFS) in Patients with GIST
Bayer HealthCare announced on the 4th of June 2012 data from the Phase III GRID (GIST – Regorafenib In Progressive Disease) trial evaluating its investi-gational drug Regorafenib in patients with metastatic and/or unresectable (GIST) whose disease had progressed despite prior treatment with Imatinib (Glivec®) and Sunitinib (Sutent).
EORTC is currently conducting A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with Retroperitoneal sarcomas (RPS) - STRASS. SPAEN has developed a leaflet/article explaining the STRASS study in non-technical terms with the aim to help patients and carers understand what the study might be able to offer them. This summary is not part of the study information and is not intended to replace any of the study information which is part of the informed consent process.
Sarcomas are rare malignant tumors, with an overall incidence of 6/105/year. Bone and soft tissue connective tissue tumours encompass more than 50 different rare histotypes and more than 150 different molecular subtypes. The incidence of individual rare sarcomas subtypes is often less than 0.5/105/year. Given the rarity of sarcomas as a group, but even more as individual entities, few prospective clinical trials testing local or systemic treatments have been performed in specific subtypes of sarcomas. Clinical trials in specific histological and molecular subtypes of sarcoma can only be performed through integrated clinical networks, centres of clinical excellence, supported by translational analysis.