Clinigen and Onxeo launch managed access programme for belinostat

Clinigen Group’s Idis Managed Access division and Onxeo agreed to launch a managed access programme for belinostat - branded Beleodaq - in Europe on Tuesday.

The AIM-traded Clinigen said belinostat was for use in patients with relapsed or refractory peripheral T-cell lymphoma.

It described PTCL as a form of blood cancer comprising of a group of rare and aggressive non-Hodgkin lymphomas - a malignant lymphoproliferative disorder.

It reportedly accounted for approximately 10%-15% of all NHL cases.

Belinostat is a histone deacetylase inhibitor used to treat refractory or relapsed PTCL, Clinigen said.

The product received accelerated approval by the US Food and Drug Administration in July 2014 due to the unmet medical need in the rare disease.

There remained no approved treatments for PTCL in Europe.

Clinigen said the programme allowed physicians to request belinostat for individual patients for whom alternative treatment options were not currently available.

That would enable patients on a named patient basis in Europe to benefit from belinostat £

"There is a huge unmet need for patients with aggressive blood cancers such as PTCL,” said Clinigen chief commercial officer Steve Glass.

“As the trusted global leader in access to unlicensed medicines, Clinigen is working in partnership with Onxeo to help patients gain access to this important medicine.”

As Clinigen and Idis MA, Glass said the pair had delivered more than 220 managed access programmes to thousands of patients.

“We help physicians access medicines when no other treatment options are available reducing unmet clinical need.

“This aligns with our mission of getting the right medicine to the right patient at the right time.”

Judith Greciet, chief executive officer of Onxeo, said consistent with the company’s efforts to address the unmet needs of people diagnosed with relapsed or refractory PTCL, they were pleased to partner with Clinigen to establish the named patient programme.

“In selected European countries in which local health authorities permit the programme, the belinostat managed access programme will allow healthcare professionals to prescribe belinostat to specific patients.”