Hutruo regulatory update

XBiotech said EMA issued a negative “trend” vote for the company's MAA for colorectal cancer candidate Hutruo. The company said the vote means it is unlikely EMA’s CHMP will recommend the candidate at its May meeting, and that “additional steps" will be required to gain approval. XBiotech said it may appeal the vote.

The vote followed a meeting with EMA at which XBiotech attempted to address major objections related to Hutruo’s clinical relevance raised in CHMP's Day 180 questions regarding the MAA. According to XBiotech's presentation at the meeting, the committee said sensitivity analyses of the individual co-primary endpoints of lean body mass and patient-reported quality of life (QOL) symptoms from the company's Phase III trial "did not indicate any statistically significant or clinically relevant differences" between Hutruo and placebo (see BioCentury, Dec. 21, 2016)...