Jean-Yves Blay is a sarcoma specialist and now president of the European Organisation for Research and Treatment of Cancer (EORTC), who is leading efforts to reshape cancer research so that every trial has a translational element that can build knowledge about the mechanisms driving the disease. In this cover story Blay talks to Cancer World about the challenges of bringing scientists and clinicians together to achieve these essential breakthroughs, given the tiny size of many of these sub populations. You can read the Cover Story here.

The FDA’s fast-track designation is for metastatic and unresectable gastrointestinal stromal tumours (GIST) in patients whose disease has progressed despite being treated with at least Novartis’ Glivec (imatinib) and Pfizer’s Sutent (sunitinib).

Bayer started enrolling patients in January for a phase III study of the compound plus best supportive care versus placebo plus best care in this specific patient group.

It is a boost for Bayer and follows the FDA’s February decision to hand regorafenib orphan status. Glivec and Sutent lead the field among those drugs already licensed to treat GIST - the most common form of sarcoma involving the gastrointestinal tract.

This multicenter phase II trial, supported by the Italian Sarcoma Group, was carried out to test the activity of the multikinase inhibitor sorafenib as second- or third-line therapy for patients with unresectable and relapsed high-grade osteosarcoma. In the last decades, only marginally effective therapies have been developed for such patients and most of them become candidates for either experimental therapies or supportive care.

Novartis discontinues clinical trial of Tasigna® for investigational use in newly diagnosed patients with unresectable and/or metastatic GIST

April 11, 2011 — Novartis announced today it is discontinuing a Phase III trial of Tasigna® (Nilotinib) for investigational use in the first-line treatment of gastrointestinal stromal tumors (GIST) based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna® (Nilotinib) is unlikely to demonstrate superiority compared to Glivec® (Imatinib), the current standard of care in this setting.