FDAnews Drug Daily Bulletin


March 23, 2006

Sales of Eli Lilly's cancer drug Gemzar are expected to grow more than 10 percent this year, despite an FDA advisory panel's rejection of an additional indication to treat advanced ovarian cancer, an analyst says.

The agency's Oncology Drugs Advisory Committee recently voted 9-2 against approving Gemzar (gemcitabine HCl) injection plus carboplatin to treat ovarian cancer that has recurred at least six months after completion of platinum-based therapy.

Prior to the meeting, FDA reviewers expressed doubts over Lilly's proposed indication, noting the drug does not improve overall survival rates and exposes patients to additional toxicity. While the FDA is not required to follow the advice of its advisers, it usually does.

An analyst with Banc of America Securities said sales estimates for the drug would remain unchanged even if the FDA agrees with the advisory committee and denies the addition of ovarian cancer to Gemzar's label.

The product is approved for pancreatic, metastatic breast and lung cancers, said analyst Chris Schott in a research note. Ovarian cancer is the smallest of Gemzar's studied oncology segments, with only 20,000 new cases each year in the U.S. compared to roughly 110,000 for the three approved indications.

"We estimate that Gemzar sales will grow 11 percent in 2006 to $1.5 billion based upon continued use in metastatic breast cancer, an indication that only accounted for 10 percent of Gemzar global 2005 sales," Schott said.