OSI Pharmaceuticals revealed yesterday that its new anticancer agent, Tarceva (erlotinib), will come before a US Food and Drug Administration advisory panel on September 13 for the treatment of advanced pancreatic cancer in combination with Eli Lilly’s Gemzar (gemcitabine).
The company is hoping to win approval early November, the deadline date for an agency response, for Tarceva in this new indication. It is already marketed along with partners Roche and Genentech in non-small cell lung cancer [[22/11/04d]], [[14/07/05d]], pulling in some 145 million Swiss francs for the Swiss giant alone in the six months to the end of June [[20/07/05a]].
The new filing, submitted back in April, included one-year survival data showing a 41% increase for Tarceva receivers over those given Gemzar alone. In addition, median survival was boosted 8% from 5.9 months on the placebo arm to 6.4 months on the Tarceva arm.
The American cancer Society predicts that in excess of 32,000 people in the USA will be diagnosed with pancreatic cancer this year, of which the large majority will die from the disease. Although it only accounts for 2% of new cancer cases, it is the fourth leading cause of all cancer deaths.