belinostat / BELEODAQ®
Belinostat is a histone deacetylase inhibitor (HDACi). It has been assessed in several clinical trials as a sole treatment (monotherapy) or in combination with other anti-cancer treatments for hematological cancers and solid tumors. Its anti-cancer activity is associated with the inhibition of cell proliferation, the induction of apoptosis (programmed cell death), the inhibition of angiogenesis and the induction of cellular differentiation.
Beleodaq® is the commercial name of belinostat for injection.
In July 2014, Beleodaq® received conditional approval from the FDA for the treatment of peripheral T-cell lymphoma. This authorization was given within an accelerated registration program which conditionally approves a drug designed for the treatment of a life-threatening disease based on predictive elements of a clinical benefit. The registration is based on the results of the phase 2 BELIEF clinical trial of 129 patients suffering from peripheral T-cell lymphoma, resistant or in relapse after at least one initial systemic treatment, which showed a response level of 25% with a median duration of response of 8.3 months and a good tolerance profile. To comply with FDA requirements, a clinical phase 3 trial is required to assess the efficacy of Beleodaq® in combination with CHOP (cyclophosphamide, hydroxydaunorubicine, oncovin, and prednisone) against CHOP in the 1st line of treatment of peripheral T-cell lymphoma.
Beleodaq® benefits from industrial protection until at least 2026. Its protection is strengthened by an orphan drug designation (ODD) in Europe and the United States, which provides commercial exclusivity. Belinostat could also be developed as an oral formulation. This would enable a significant extension of the intellectual property and facilitate the use of belinostat in combination with other anti-cancer agents.
Finally, since April 2017, Beleodaq has also been made available at the request of healthcare professionals as part of a Named Patient Program (NPP) run by Clinigen (for more information on this programme, visit the "Licensing Agreements and Collaborations" section below).
As part of a collaboration and licensing agreement entered into in 2010, Spectrum Pharmaceuticals was co‑developing Beleodaq® in partnership with Onxeo and was in charge of its promotion to oncology and hematology experts in the USA. This agreement provided for milestone payments by Spectrum Pharmaceuticals to the Company when certain regulatory stages have been reached and for royalties and payments on sales performances.
On March 1, 2019, Spectrum Pharmaceuticals (SPPI) announced the completion of the sale of its seven hematology/oncology products approved by the FDA, including Beleodaq®, to Acrotech Biopharma LLC, a US subsidiary of the Aurobindo group. The Company does not foresee any significant impact of this transaction on the activities and results of Beleodaq® for Onxeo.
In 2016, the Company signed a licensing agreement with Pint Pharma for the registration and marketing of Beleodaq® in PTCL in several countries in Latin America. This agreement gave rise to an initial payment on signature and provides for payments based on regulatory and revenue milestones, as well as royalties on net sales of Beleodaq®, for a total value greater than $20 million.
In April 2017 (access the related press release), Onxeo and Clinigen Group have set up a European Managed Access Program (MAP) consisting in a Named Patient Program (NPP). This program allows the use of Beleodaq® at the request of physicians for patients who are directly designated, even if the product doesn’t have a marketing authorization (MA) in Europe. This waiver to the regular status of drugs with MA is strictly regulated and only patients without available therapeutic options can benefit from this program through individualized requests from their physician.
- Healthcare professionals1 can obtain more information on the NPP for Beleodaq® by sending queries on Clinigen’s portal at this address : https://www.clinigengroup.com/about-cliniport/ , or directly by e-mail to firstname.lastname@example.org.
- If you are a patient or healthcare professional wishing to report an adverse event in the context of this Named Patient Program, please refer to the PHARMACOVIGILANCE section in blue below for more information and instructions.
1 Healthcare professionals who practice in France are invited visit the French version of this page and to consult the "Référentiel des ATU nominatives" directly on the website of the ANSM at this address (https://www.ansm.sante.fr/Activites/Autorisations-temporaires-d-utilisation-ATU/Referentiel-des-ATU-nominatives) where they will find all necessary information and instructions to request Beleodaq®.
- FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma.
Lee HZ et al. Clin Cancer Res. 2015 Jun 15;21(12):2666-70.
- Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study.
O'Connor OA et al. J Clin Oncol. 2015 Aug 10;33(23):2492-9.
- A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma.
Foss F et al. Br J Haematol. 2015 Mar;168(6):811-9.
- A phase I clinical trial of the histone deacetylase inhibitor belinostat in patients with advanced hematological neoplasia.
Gimsing P et al. Eur J Haematol. 2008 Sep;81(3):170-6.
Posters AACR 2015
Lymphoma is the most common blood cancer*. Hodgkin’s and non-Hodgkin’s lymphoma are its two main forms. Lymphoma occurs when the lymphocytes, a type of white blood cell, increase abnormally and accumulate in one or more lymphatic ganglions or in lymphatic tissue. Two types of lymphocytes may develop: B lymphocytes (B cells) and T lymphocytes (T cells). Peripheral T-Cell Lymphoma (PTCL) is a sub-type of non-Hodgkin’s lymphoma which affects T cells. In the United States, PTCL accounts for around 10 to 15% of non-Hodgkin’s lymphoma and its global incidence is estimated at 12,000 cases each year. Currently no 2nd line treatment is available in Europe once the disease has progressed after a 1st line of treatment. *Lymphoma Research Foundation (www.lymphoma.org)
Pharmacovigilance is defined as science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related issue (WHO definition - www.who.int).
Onxeo's pharmacovigilance aims to improve patient care and safety with respect to the use of belinostat. Onxeo supports public health programs by providing reliable and objective information for the effective evaluation of the benefit-risk profile of its product and takes appropriate measures to collect and collect all reports of suspected adverse reactions associated with belinostat.
Patients and health care providers are encouraged to report any possible side effects and/ or pregnancy during treatment with belinostat by attaching the relevant completed document(s) :
through the dedicated form below:
* required field
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