A Phase III trial evaluating the anticancer drug Tarceva found that using the drug immediately after initial chemotherapy against advanced non-small-cell lung cancer (NSCLC) significantly extends overall patient survival and delays disease progression. Roche says treating patients with Tarceva immediately following first-line chemotherapy rather than waiting for the cancer to reappear or spread, represents a new approach in the fight against NSCLC.
Roche and OSI Pharmaceuticals, its U.S. partner for Tarceva, aim to use this survival data to support their European and U.S. applications for the drug as a first-line maintenance therapy for advanced NSCLC, which were filed during March.
Tarceva is an oral drug targeting the epidermal growth factor receptor. It has been available in the EU since September 2005 and in the U.S. since November 2004, as a second-line treatment for advanced NSCLC after the failure of chemotherapy. It is now available in over 90 countries for the NSCLC indication and in 70 countries for the treatment of pancreatic cancer in combination with gemcitabine, according to Roche and OSI.
Roche reported worldwide sales of Tarceva were up 23% in 2008, to CHF 1.2 billion ($1.1 billion). Primary contributions came from Western Europe and the Asia-Pacific region. Double-digit sales growth was also maintained in the U.S.
OSI receives a 50% profit share on U.S. sales of Tarceva and a 21% royalty on sales in the rest of the world. The company said non-U.S. sales of the drug increased from $470 million in 2007 to $665 million in 2008. U.S. sales were $457 million in 2008, up from $417 million in 2007.