Despite stating in briefing papers that Genentech and OSI Pharmaceuticals’ Tarceva (erlotinib) did not show a clinically meaningful effect in treating pancreatic cancer [[13/09/05c]], a US Food and Drug Administration advisory panel yesterday gave its backing to the drug. The committee members decided that – although the survival benefit of adding Tarceva into a Gemzar regimen was modest – it was a valid improvement. “This is a positive study in a tough disease,” commented panel member Maha Hussain. The average survival time of a patient diagnosed with pancreatic cancer is six months.
In a press release issued following the decision, Genentech and OSI said Tarceva is the first drug in a Phase III trial to have shown a significant improvement in overall survival when added to Eli Lilly’s Gemzar (gemcitabine) in the first line treatment of pancreatic cancer. Findings showed a 23% improvement in overall survival amongst patients given the dual therapy, plus a significant benefit in terms of progression-free survival. At the end of one year, 23% of patients in the Tarceva/Gemzar group were alive, versus 17% of those given Gemzar alone.
The FDA panel, however, focused on median survival and found the difference to be just 12 days between the two groups (6.37 months versus 5.95 months). Updated information, though, presented to the agency in June, found a greater difference in median survival of five weeks, or 8.7 months versus 7.6 months. Overall, the committee members voted unanimously that the data presented were “statistically persuasive” and 11 to two that the size of the survival benefit was “clinically important.”
A decision on approvability will be made by November 2, and Genentech and OSI will be waiting with baited breath to see whether the FDA follows the recommendations laid out by its advisory panel. Tarceva is already marketed for non-small cell lung cancer and the companies will be keen to expand on its sales potential: the compound brought in 145 million Swiss francs for European partner Roche during the first six months of the year [[20/07/05a]]. More than 216,000 people around the world are diagnosed each year with pancreatic cancer, according to the World Health Organisation.