Lilly’s Gastric Cancer Drug Wins Approval From U.S. FDA

Eli Lilly & Co. (LLY)’s gastric cancer treatment, a drug that analysts project may generate more than $1 billion in sales, gained approval from U.S. regulators.

The therapy, ramucirumab, to be sold under the brand name Cyramza, was cleared for patients with advanced stomach cancer and those with a form of cancer located in the area of the body where the esophagus joins the stomach, the Food and Drug Administration said in a statement. Cyramza was approved under a priority review for those whose cancer can’t be surgically removed or has spread after being treated with other medicines.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

About 22,000 new cases of stomach cancer will be diagnosed this year and about 11,000 Americans will die of the disease, according to the National Cancer Institute.

Lilly is seeking new products in cancer and diabetes to overcome the loss of some of its best-selling medicines. In December, it lost patent protection on the anti-depressant Cymbalta, the top seller that brought in $5.08 billion last year, 22 percent of the Indianapolis-based company’s revenue.

Lilly gained less than 1 percent to $60.86 at the close yesterday before the approval was announced. The drugmaker’s shares have increased 6 percent in the past 12 months.

Improving Survival

In a study released last year, ramucirumab was found to lengthen survival in patients whose stomach cancer came back or started progressing again after initial treatment with chemotherapy. In the 355-person trial, patients getting the drug lived a median of 5.2 months, compared with 3.8 months on placebo. It also stopped the disease from growing for 2.1 months, compared with 1.3 months on placebo.

“There is a high unmet medical need in patients with this disease,” Charles Fuchs, director of the gastrointestinal malignancy program at Dana-Farber Cancer Institute in Boston, said in a statement. “This approval represents a meaningful advance for patients and gives those of us who treat them an important new second-line treatment option.”

Gastric cancer often begins in the stomach’s inner layer, then moves deeper before metastasizing into neighboring organs. It is typically treated with surgery, radiation and chemotherapy, according to the National Cancer Institute.

Ramucirumab belongs to a family of drugs called vascular endothelial growth factor receptor, or VEGF, inhibitors. The drugs cut off a tumor’s blood supply to kill it.

Lilly is also studying the drug in lung, liver and colorectal cancers. A trial in breast cancer failed to meet its effectiveness goals in September. Analysts have projected it to be a major seller for Lilly, with $1.40 billion in revenue by 2020, according to estimates compiled by Bloomberg.

Lilly obtained the drug through its acquisition of ImClone Systems Inc. in 2008.

To contact the reporter on this story: Drew Armstrong in New York at darmstrong17@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Andrew Pollack

Press spacebar to pause and continue. Press esc to stop.

Bloomberg reserves the right to remove comments but is under no obligation to do so, or to explain individual moderation decisions.

Please enable JavaScript to view the comments powered by Disqus.