At 25th of Feb. 2013 the U.S. Food and Drug Administration expanded the approved use of Bayer Pharmaceutical's drug Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease. Stivarga was approved in September 2012 to treat colorectal cancer.
For the first time ever, scientists have identified a specific genetic risk factor that, when present, significantly increases the chances that an individual will develop chordoma. This discovery – a milestone outcome of the Chordoma Foundation’s significant investment in the Chordoma Genome Project over the past three years – provides unprecedented insight into how chordoma forms, and potentially how to effectively treat it.
The multi-tyrosine kinase inhibitor regorafenib significantly delays disease progression in virtually all subgroups of patients with gastrointestinal stromal tumor (GIST) in the second-line setting, and may even confer benefits when continued after progression, according to subgroup and post-progression analyses of the phase III GRID trial presented at the ESMO 2012 Congress. The current exploratory analyses were presented at ESMO 2012 by Peter Reichardt, MD, PhD, of HELIOS Klinikum in Bad Saarow, Germany. Read more at OncLive. At OncLive there are also related articles and videos on different aspects of GIST treatment available.
Rare cancers represent more than 20% of all cancer cases diagnosed in the EU each year and affect more than 4 million people in the EU. Patients with rare cancers – such as Sarcomas, GIST and Desmoids - are faced with particular challenges, including late or incorrect diagnosis, difficulties finding clinical expertise and accessing appropriate treatments, difficulties carrying out clinical studies due to the small number of patients, possible lack of interest in developing new therapies, high uncertainty in clinical decision-making, and the scarcity of available registries and tissue banks.
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.