Roche lands EU Kadcyla approval, ducks EMA criticism
Roche is riding a wave of good news. The company announced Wednesday that the EU greenlighted Kadcyla for HER2-positive breast cancer. The US approved the drug this year, but the OK was accompanied by questions about its viability. The so-called “super Herceptin” was expected to cost around $94,000 for a standard course of treatment, and the approval overlapped just as a pricing standoff between Memorial Sloan-Kettering and Sanofi ended with the drugmaker yielding on price.
The company is also breathing easy-ish because the European Medicines Agency decided that the firm's failure to reveal 80,000 adverse-events reports was no big deal. FiercePharma reports that Roche says the number of unreported AEs was really 23,000 and the EMA says these incidents were not associated with any negative outcomes.