FDA OKs Lilly's blockbuster hopeful ramucirumab for stomach cancer

Courtesy of Eli Lilly

The bull case for Eli Lilly ($LLY) and its long-stunted R&D operation rests largely on a potential string of FDA approvals for the much-hyped ramucirumab, and the Indiana drugmaker picked up its first, clearing the treatment to treat stomach cancer.

Ramucirumab, which Lilly acquired in its $6.5 billion deal for ImClone back in 2008, is a VEGF blocker that works by starving tumors of the blood supply they need to thrive. The FDA's approval for stomach cancer is based on a 355-subject trial in which the drug boosted overall survival by about 37% in patients with unresectable or metastatic stomach cancer, the agency said. Lilly plans to sell the drug as Cyramza.

The approval is a positive start to what will likely be a make-or-break 2014 for Lilly's star oncology candidate. Peak sales estimates for ramucirumab reach as high as $1.3 billion a year, but the treatment's potential depends on down-the-line approvals in three other cancers. Lilly startled investors last fall when ramucirumab failed a late-stage trial in breast cancer, but the drug has since performed well in a Phase III lung cancer study, and the company expects to report out results in liver and colorectal cancers later this year.

If Lilly can run the Phase III table and convince the FDA to bless ramucirumab for three more indications, it'll spell some vindication for CEO John Lechleiter and his dogged commitment to the company's setback-plagued pipeline. After late-stage stumbles sank contenders in Alzheimer's disease, schizophrenia and arthritis, Lilly's late-stage hopes fall on ramucirumab and the diabetes prospect dulaglutide, two drugs Lechleiter has said will mark "the beginning of our return to growth." 

Lilly's drought of new drug approvals stretches back to 2009, a 5-year period that includes only one other new drug approval for the pharma giant.

FDA cancer chief Richard Pazdur

For now, with its market debut on the horizon, ramucirumab presents a potential solution for the roughly 22,220 Americans who will be diagnosed with stomach cancer this year, according to National Cancer Institute estimates.

"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," FDA cancer chief Dr. Richard Pazdur said in a statement. "Cyramza is a new treatment option that has demonstrated an ability to extend patients' lives and slow tumor growth."

- read the statement