Date: 2017-04-24
Type of information: Initiation of patient enrollment
phase:
Announcement: initiation of patient enrollment
Company: Clinigen (UK) Onxeo (France)
Product: belinostat (Beleodaq®)
Action mechanism: histone deacetylase inhibitor. Belinostat is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin, cis-retinoic acid, azacytidine, 5-FU, etoposide and bortezomib for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: Arrest growth of cancer cells (including drug-resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents. Beleodaq® (belinostat) has received accelerated approval by the FDA for the treatment of relapsed or refractory peripheral T-cell lymphoma in July 2014.
Disease: relapsed or refractory peripheral T-cell lymphoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest news: • On April 24, 2017, Clinigen Group plc’s Idis Managed Access (MA) division and Onxeo have agreed to launch a Managed Access programme for belinostat (Beleodaq®) in Europe. Belinostat is for use in patients with relapsed or refractory peripheral T-cell lymphoma. This form of blood cancer is comprising of a group of rare and aggressive non-Hodgkin lymphomas (NHL), a malignant lymphoproliferative disorder. PTCL accounts for approximately 10%-15% of all NHL cases. There are no approved treatments for PTCL in Europe. The programme will be launched in United Kingdom, Germany, France, Spain, Italy, Denmark, Sweden, Norway, Finland, Belgium, The Netherlands, Luxembourg, and Austria. The programme allows physicians to request belinostat for individual patients for whom alternative treatment options are not currently available. This enables patients on a named patient basis in Europe to benefit from belinostat treatment ahead of a potential European approval.
