Lilly's Gemzar Cleared For Prostate Cancer In USA

Eli Lilly has been granted approval to market its nucleoside analog anticancer drug Gemzar (gem-citabine) for the first-line treatment of pancreatic cancer by the US Food and Drug Administration. The drug was due to be launched to specialist wholesalers in the USA on May 24, as the Marketletter went to press.

Gemzar is indicated as first-line treatment for patients with locally-advanced or metastatic adenocarcinoma of the pancreas, as well as in patients who have already been treated with 5-fluorouracil. Treatment with the drug will cost approximately $1,375 per month, depending on the size of the patient. The wholesale price of Gemzar will be $50.93 for a 200mg vial, according to Lilly.

Lilly submitted two clinical trials to the FDA in support of its application for approval. In the first of these, JHAY, a Phase III trial which compared Gemzar to 5-fluorouracil treatment in 126 patients, one-year survival was found to be 18% and 2% respectively. This translated to approximately a one-and-a-half month improvement in median survival for the Gemzar-treated patients, or a 30% improvement.