FrostPharma takes another step in its growth journey of becoming a leading European Specialty Pharma company, by being authorized by IDEOGEN as the exclusive Nordic representative to support patient access of Beleodaq (belinostat), a medicine that provide new hope for late-stage peripheral T-cell lymphoma patients.
Beleodaq (belinostat) belong to the class of drugs known as histone deacetylase (HDAC) inhibitors. It works by affecting gene expression and the growth and division of cells. It is used to treat relapsed, refractory peripheral T-cell lymphoma. Beleodaq is approved by the FDA, and in Europe it is now available as an un-licenced pharmaceutical2.
The FDA approval was based on the phase 2-study, BELIEF, which included 120 patients in a single-arm study. The included patients had previously received between one to eight treatment regimens (median two regimens) and were at inclusion not responding to treatment or in relapse. Previous treatments included multiagent regimens, single-agent regimens as well as stem-cell transplantation.
Beleodaq was administered as a daily 30-minutes intravenous infusion for 5 days every 3rd week. The primary endpoint, overall response rate, was reached by 31 patients (25,8%) including 13 complete (10,8%) and 18 partial responses (15%). Median duration of response was 13,6 months. Twelve responding patients underwent stem-cell transplantation.
Beleodaq was well tolerated in this heavily pretreated population with few patients requiring dose reductions (12,4%). There was a low incidence of severe (grade 3 and 4) hematologic toxicities (thrombocytopenia 7%, neutropenia 6,2%, anaemia 10,9%)3.
A phase 2/3, randomized, open-label study in newly diagnosed patients with peripheral T-cell lymphoma is planned to start recruitment in a multinational trial. This study compares the efficacy and safety of the combination of Beleodaq-CHOP or Folotyn-COP to CHOP regimen alone4.
As Beleodaq is now available as an additional option for severely sick T-cell lymphoma patients in the Nordics, FrostPharma keeps its promise to the patients, which is identifying unmet needs among patients within the hospital setting and based on that search for and provide solutions for those needs. FrostPharma is active within many different therapeutical areas, and Beleodaq serves as the pharmaceutical within haematology/oncology, hence provide the foundation for a new step in our expansion journey.
Beleodaq (belinostat) is a histone deacetylase inhibitor (HDAC). It is approved by the FDA and is provided in the Nordics as an unlicensed pharmaceutical for patients with late stage peripheral T-cell lymphoma.
Beleodaq (belinostat) for injection, 500 mg lyophilized powder in single-dose vials for reconstitution. Given to patients during 30 minutes intravenous infusion day 1 to 5 in a 3 week cycle.
About T-cell lymphoma
Peripheral T-cell lymphomas (PTCL) is a rare and heterogeneous group of highly aggressive non-Hodgkin lymphomas (NHL). With a 5-year survival rate of approximately 30%, they are associated with poor treatment outcome.1
FrostPharma is an entrepreneurial Swedish Specialty Pharma company specializing in the commercialization of value-adding medicines. FrostPharma signed its first product distribution agreement in 2017, and since then +40 products have been added to the therapy agnostic portfolio through a strong agreement deal-flow, as well as through the development of proprietary products. The company has an established specialty pharma platform across the Nordics, and now actively plan to expand to additional EU countries. The FrostPharma portfolio of products are primarily oriented toward hospital use, and hospital initiation. FrostPharma has also developed a separate division offering sustainable solutions to petroleum-based plastics across the Healthcare sector.
The Swiss pharmaceutical company IDEOGEN holds the exclusive license for the Managed Access Program for BELEODAQ® (belinostat) and FOLOTYN® (Pralatrexate) in Europe, MENA & CIS. Ideogen commences their strategic partnership with FrostPharma, a preeminent presence in the Nordic region known for its multifaceted commitment to multiple therapeutic areas.
For further information please contact
Rebecka Grund, COO
1. T-cellslymfom, nationellt vårdprogram Sverige, 2021-02-16, version 2.0
2. FDA Prescribing Information. h https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206256s003lbl.pdf
3. O´Connor et al. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Result of the Pivotal Phase II BELIEF (CLN-19) Study. J Clin Oncol 2015, 33:2492-2499
4. A phase 2/3, randomized, open-label study comparing the efficacy and safety to the combination of Beleodaq-CHOP or Folotyn-COP to the CHOP- regimen alone in newly diagnosed patients with peripheral T-cell lymphoma. Clinicaltrials.gov. Identifier: NCT06072131