Lilly's cancer drug ramu granted gastric indication

Share this article:
Eli Lilly
Eli Lilly

Lilly's advanced gastric cancer injection, Cyramza (ramucirumab), received US approval today, the drugmaker announced. Lilly Oncology picked up the cancer asset from imClone in 2008 and was granted orphan drug designation by FDA for today's approved indication.

Cyramza's approval is a unique one, as it's the first drug of its kind cleared for use in advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (cancer of the esophagus).

Cyramza was approved from results of Lilly's Phase-III REGARD trial, which saw the drug improve median survival by 5.2 months compared to placebo (3.8 months).

In an investor note from February, ISI Group analyst Mark Schoenebaum modeled that the drug could see peak sales of $600 million solely from its gastric indications.

Ramucirumab operates in a similar fashion to Roche/Genetech's Avastin, by targeting a tumor-created signal protein, VEGF. Avastin saw overall sales of $7 billion in 2013, up 13% from the year prior.

Following in Avastin's blockbuster-sized footsteps, Lilly has investigated ramu for use in non-small cell lung cancer as well as colorectal cancer. The drug was also in trials for breast cancer earlier this year, but failed to meet its primary endpoint. Top line results for ramu in liver and colorectal cancer are expected in 2014.

Lilly announced in February that ramu had completed its Phase-III trial in non-small cell lung cancer and would file for the indication this year. Schoenebaum modeled at the time, that if approved, this could translate into another $200 million in peak sales.

Schoenebaum also forecasted that second-line indications in metastatic colorectal cancer and hepatocellular carcinoma (liver) cancer could add another $200 million in peak sales.

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Channel


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...