Clinigen to manage programme for new lung cancer drug

BURTON-upon-Trent pharmaceuticals firm Clinigen Group has been appointed as specialist partner in charge of managing the global access programme for a cancer drug.

It will oversee the programme for Clovis Oncology’s rociletinib for the treatment of EGFR Mutant Non-Small Cell Lung Cancer.

This programme – which Clinigen is managing in Europe initially – is intended to allow access to the drug for individual named patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutant T790M-positive NSCLC who have previously been treated with an EGFR-targeted therapy and for whom their physician determines that there is no satisfactory alternative therapy or rociletinib clinical trial available.

Lung cancer is the most common cancer worldwide with 1.35m new cases annually. Of these, approximately 85% of cases are NSCLC. This is a rapidly progressing cancer with a five-year survival rate of less than 5% in advanced patients.

Patients with an EGFR activating mutation often respond well to marketed EGFR inhibitor therapies. However, most will ultimately see their cancer progress, with approximately 60% developing acquired resistance from a second “gatekeeper” mutation, T790M.

Currently, there are no therapies approved for the treatment of this mutation.

Clinigen’s managed access programs division will provide rociletinib to individual patients in selected countries in Europe initially, until the approval and launch of the drug.

Simon Estcourt, managing director, managed access programs, Clinigen Group said: “Non-small cell lung cancer is a devastating disease affecting a huge number of people worldwide. Our experience in managing access programs on a global scale will enable us to provide critically ill patients with rapid access to rociletinib before it is commercially available.

“We look forward to working with Clovis to address this area of unmet medical need.”