Clinigen : Future Oncology publishes dexrazoxane article supporting EC removal of restrictions for use in children and adolescents

4 June 2018

Future Oncology publishes dexrazoxane article supporting EC removal of restrictions for use in children and adolescents

Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, notes the publication in Future Oncology of a peer reviewed article by expert physicians evaluating recent research and publications on dexrazoxane, marketed by Clinigen as Cardioxane®. The physicians concluded that dexrazoxane's cardioprotectant benefits outweighed the risks for its use in children and adolescent cancer patients, which is consistent with the EC's change of label approval in 2017.

The article, 'Risk‐benefit of dexrazoxane for preventing anthracycline‐related cardiotoxicity: re‐evaluating the European labelling' by Dr. Peter Reichardt et al, was published online in the MEDLINE‐indexed journal Future Oncology on 11 May 2018.

The key findings from the article were:

•  Cardioxane® is

  • o An effective cardioprotectant in children and adolescents

  • o Not associated with an increased risk of second primary malignancies

  • o Not significantly associated with excess mortality

•  Cardioxane® may be associated with specific but reversible toxicities, including myelosuppression

•  Cardioxane® therapy does not impair anthracycline's antitumor efficacy

The full open access article can be found here:https://www.futuremedicine.com/doi/10.2217/fon‐2018‐0210

Cardioxane® protects the heart against the toxic effects of high dose anthracycline chemotherapy and has been used in cancer patients since the 1980s. In 2011, upon an Article 31 referral, the European Medicines Agency reviewed its safety in children after signals emerged of increased risk of infection, bone marrow suppression and second primary malignancies. This led to a restricted indication and introduction of a paediatric contraindication.

From 2014 a group of internationally recognised paediatric oncologists and cardiologists supported by a multi‐ disciplinary team from Clinigen started to identify newly published trials on the subject. The aim was to submit safety and efficacy data to the regulatory authorities to address the safety concerns and potentially update the label. In August 2017 Clinigen received approval for the product information to be updated following a positive opinion issued by the EMA Committee for Medicinal products for Human Use (CHMP) and a positive European Commission Decision.

Since the change in the product information, Clinigen has been implementing appropriate measures to ensure the continued safe use of the product and to expand clinical understanding. The Group has been submitting amendments to the labelling in countries where Cardioxane® licences are held.

Merav Edan, Head of regulatory affairs from Clinigen said:

"Implementing the label change for Dexrazoxane was a major regulatory achievement for Clinigen last year and we are proud to have driven it through. We could not have done it without the growing support from key opinion leaders and physicians wanting to help their patients."

Dr Henno Welgemoed, Director of Medical affairs from Clinigen said:

"Articles such as the one published in Future Oncology add to the body of peer reviewed work supporting the benefits of dexrazoxane as a cardioprotectant and will expand the clinical understanding of its benefits to the paediatric and adolescent population."

More information on Cardioxane® is available for healthcare professionals here:https://www.clinigengroup.com/medicines‐services/commercial‐medicines/Cardioxane®/

‐ Ends -

Cardioxane® is a cardioprotective agent used to prevent chronic cumulative cardiotoxicity caused by anthracycline use in advanced and/or metastatic breast cancer patients who have received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required. Cardioxane® is administered by intravenous infusion. It is believed to work by binding to metal ions, thus decreasing the formation of intracellular superoxide radicals and preventing cardiotoxicity.

Cardioxane® was initially licensed in 1992. Subsequently, Novartis acquired the product as part of the 2006 acquisition of Chiron. The product is currently licensed for sale in 23 markets around the world, including 10 in Latin America. Within the EU, Cardioxane® underwent a revision to its label in 2011 as a result of an Article 31 referral, restricting its licensed indication and introducing a paediatric contraindication. In July 2017, the EC approved the removal of the contraindication in children and adolescent planned to receive high cumulative doses of anthracycline therapy.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. Clinigen acquired Quantum Pharma in November 2017.

For more information, please visitwww.clinigengroup.com