Roche has negotiated a worldwide sublicense from Genzyme to EGFR mutation IP that will allow it to develop a companion diagnostic for use alongside its Tarceva (erlotinib) therapy for patients with non-small-cell lung cancer (NSCLC). The PCR-based test for identifying EGFR-activating mutations will be developed in collaboration with OSI Pharmaceuticals, for use on Roche’s Cobas 4800 System.
“The companion diagnostic test will use Roche’s proprietary molecular diagnostics technology,” remarks Daniel O’Day, head of Roche’s diagnostics division. “The aim is to provide a simple tool that will quickly identify EGFR-activating mutations and so enhance physicians’ ability to customize the use of Tarceva for people with advanced NSCLC.
Roche has previously applied to the European Medicines Agency for clearance to extend the current label for Tarceva to include first-line therapy of patients with advanced NSCLC that exhibit EGFR-activating mutations. The drug is currently approved in the EU and U.S. for use in maintenance and second-line treatment for advanced or metastatic NSCLC with and without EGFR-activating mutations. The drug is separately approved as part of combination therapy for advanced-stage pancreatic cancer.
The Cobas platform is currently available in Europe, although not the U.S. In the EU it is approved for detecting infectious microorganisms including human papillomavirus, chlamydia, and gonorrhea. Roche says it is exploring other potential oncology applications for the system in addition to the planned EGFR test.
Roche reported Tarceva sales of CHF674 million (about $690 million) in the first half of 2010, up 8% on the previous year’s period. The firm said sales increases were fueled primarily by growth in the international region (up 14%) and the U.S. (up 6%). Positive sales growth of 28% in Japan reflected the drug’s continuing penetration into the Japanese market, Roche points out. Tarceva was the firm’s tenth best-selling pharmaceutical in the first half of 2010.