The plan for Eli Lilly's ($LLY) Cyramza has always been to rack up a string of approvals to vault the drug into blockbuster territory. As of Friday, the Indianapolis drugmaker is one step closer to achieving that goal.
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| CDER's Richard Pazdur |
The FDA has green-lighted the cancer-fighter in combination with chemo drug docetaxel as a treatment for non-small cell lung cancer, a malady the National Cancer Institute estimates will afflict 224,210 new patients in the U.S. this year. It's the third indication Cyramza has snagged in 2014, following agency approvals in advanced stomach cancer and advanced gastric cancer.
"The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients," the Center for Drug Evaluation and Research's Richard Pazdur said in a statement.
It could also yield an important revenue bump for Eli Lilly, which is facing a hefty sales decline in the wake of patent expirations on top sellers Cymbalta and Evista. The company has predicted this year could be its worse yet, and third-quarter numbers seemed to support that forecast. Net income plunged 58% to $501 million from last year's $1.02 billion, with Cymbalta sales diving 73% and Evista sales dropping by 65%.
The lung cancer go-ahead could help Cyramza sales reach $1.35 billion in 2020, JPMorgan analyst Chris Schott told investors in September. A second-line colorectal cancer nod--which looks possible after a recent study of 1,000 patients turned out positive survival data--could boost Cyramza's top-line firepower, too.
It hasn't been all smooth sailing for Cyramza, however. Last fall, the drug flopped in a late-stage breast cancer trial, failing to hit its primary endpoint for progression-free survival.
- read the FDA's release
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