Regulator notes potential cancer risk for weekly Byetta

A top regulator at the FDA has noted that data on the long-acting diabetes drug Byetta from Amylin and Eli Lilly indicate that the drug could be linked to a higher risk of cancer similar to that seen in Novo Nordisk's Victoza. Both are GLP-1 analogs. Analysts were quick to note that if the FDA responds with a black box warning on the risk, the companies were likely to see a slower uptake. The FDA temporarily delayed its decision on the once-weekly therapy after raising a few questions about the program. Regulators didn't ask for a new study, which would have caused an indefinite delay. Report

Suggested Articles

Zentalis is coming out of stealth with an $85 million series C, which will propel its lead programs into pivotal trials and broaden its pipeline.

The planned takeover centers on ARQ 531, a BTK inhibitor that triggered durable responses in patients with B-cell malignancies.

At ASH, Dana-Farber researchers presented promising preclinical data on AMG 701, Amgen's long-lasting BiTE for multiple myeloma, but rivals loom.