Lilly gets preliminary NICE thumbs-down for Cyramza in stomach cancer

Eli Lilly's Indianapolis, IN, headquarters--Courtesy of Eli Lilly

Eli Lilly ($LLY) has high hopes for its new oncology med Cyramza, notching U.S. approvals for the drug last year to counter increased competition to older products. But the company could face a setback with Cyramza across the pond, as the U.K.'s cost gatekeeper is holding off on recommending the drug to treat certain forms of stomach cancer.

The National Institute for Health and Care Excellence's (NICE) appraisal committee gave a thumbs-down to Cyramza (ramucirumab) for use alone or in combination with another cancer drug, paclitaxel. The drug's cost rings in at about £42,000 ($64,670) per person, NICE said in an appraisal document, well and above the watchdog's usual price recommendations.

But it's not just the price tag that has NICE concerned. It's the cost in light of Cyramza's survival data. In one trial, patients who took Cyramza and paclitaxel survived just 2.27 months longer on average than those in the control arm. In another study, Cyramza beat out placebo by adding 1.4 months to patients' lives, NICE said in its appraisal document.

NICE is taking public comments for Cyramza until Oct. 6 and will hold a second appraisal committee meeting on Oct. 20, the cost gatekeeper said.

Meanwhile, Lilly is chasing blockbuster sales of the drug with expanded approvals in the U.S. Last year, the FDA signed off on Cyramza to treat stomach cancer, advanced gastric cancer and lung cancer, echoing the agency's commitment to ushering through innovative therapies that offer more treatment options for patients. The greenlight for lung cancer could be especially fruitful, helping catapult sales for Cyramza to $1.35 billion in 2020, JPMorgan analyst Chris Schott told investors last year.

At least so far, the drug's U.S. launch "looks quite strong," Evercore ISI analyst Mark Schoenebaum said in a note to investors earlier this year, setting the stage for more growth. Cyramza roped in $88 million in Q2 sales. Lilly is counting on Cyramza, along with other new launches, to make up for losses from off-patent meds such as antidepressant Cymbalta and osteoporosis drug Evista.

- read the NICE appraisal document (PDF)
- here's the PharmaTimes story

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