DUBLIN – The EMA has diverged sharply from the FDA in denying approval of Puma Biotechnology Ltd.'s breast cancer drug, Nerlynx (neratinib). The EMA's Committee on Human Medicinal Products (CHMP) formally issued a negative opinion on the Puma application last week, on the grounds that it was uncertain that the modest clinical benefit seen in clinical trials – 94 percent of patients on the drug remained relapse-free for two years vs. 92 percent of patients on placebo – would be repeated in clinical practice. The drug, moreover, has a high burden of gastrointestinal side effects, including severe diarrhea, which can be difficult to manage.