Biotech giant Amgen announced in a press release Saturday that its PAVES phase 3 trial to evaluate colorectal cancer patients taking the white blood cell-boosting drug Neulasta met its primary endpoint.
In the trial, Neulasta significantly reduced the incidence of febrile neutropenia, which is low white blood cell count combined with fever. The drug more than halved the percent of chemotherapy patients contracting grade 3 or 4 febrile neutropenia as compared to a placebo group, the company said, cutting the incidence from 5.7% to 2.4%.
Amgen Executive Vice President of Research and Development Dr. Sean E. Harper was quoted in the press release as saying, "In addition to providing new data on Neulasta, we believe PAVES will provide valuable information to the oncology community on commonly used chemotherapy regimens."
The company will provide further details on other trial endpoints, such as overall survival and response rate, later. Neulasta was first approved by the FDA back in 2002, with Amgen continuing to provide more data on its blockbuster drug through follow-up trials. Neulasta sold more than $4 billion around the world for the full year 2012, with sales growing 4%.
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