Europeans with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have no current alternative treatment options may soon get access to Onxeo‘s Beleodaq (belinostat), under a managed access program lauched by France’s Onxeo and the British-based Clinigen Group.
The U.S. Food and Drug Administration (FDA) granted Beleodaq accelerated approval in July 2014 due to the large unmet need for treatments for this rare disease. But no similar therapies are available in Europe for PTCL patients who progressed after first-line treatment.
“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,” Steve Glass, chief commercial officer for Clinigen’s North American and European operations, said in a press release. “As Clinigen and Idis MA, we have delivered over 220 managed access programs to thousands of patients. We help physicians access medicines when no other treatment options are available. This aligns with our mission of getting the right medicine to the right patient at the right time.”
PTCL, a rare form of blood cancer, accounts for 10 to 15 percent of all non-Hodgkin lymphomas, with about 12,000 new cases diagnosed globally each year. Beleodaq is a histone deacetylase inhibitor (HDAC), meaning induces changes in the DNA of major genes involved in cancer progression.
The FDA based its approval on data from the BELIEF Phase 2 trial (NCT00865969), which studied 129 PTCL patients who were resistant or relapsed after at least one prior systemic treatment. Results showed that 25 percent of patients responded to the treatment, with a median response duration of 8.3 months, and a good tolerance profile.
Onxeo plans to begin a Phase 3 trial assessing Beleodaq as a first-line treatment for PTLC, in combination with a CHOP chemotherapy regimen.
“Consistent with our efforts to address the unmet needs of people diagnosed with relapsed or refractory PTCL, we are pleased to partner with Clinigen to establish this named patient program,” said Onxeo CEO Judith Greciet, adding that in selected European countries that allow it, “the belinostat managed access program will allow healthcare professionals to prescribe belinostat to specific patients.”