OREANDA-NEWS. Clinigen Group plc ('Clinigen', AIM: CLIN) today announce the initiation of a global access program in Europe for rociletinib (CO-1686) which is being developed for the treatment of advanced non-small cell lung cancer (NSCLC).

This program is intended to allow access to rociletinib 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 1.35 million 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, including Tarceva® (erlotinib), Iressa® (gefitinib) and Gilotrif® (afatinib). 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.

Rociletinib is an oral, potent, mutant selective inhibitor of EGFR, which is currently in Phase II/III development for the treatment of NSCLC. In 2014, rociletinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).

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."

"At Clovis, we are preparing our near-term regulatory submissions seeking approval in the U.S. and E.U. for rociletinib for patients with advanced EGFR-mutant lung cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are very pleased to be working with Clinigen to make rociletinib available for patients until this therapy is commercially available in Europe."