EU cancer drugs rejection shows contrasts with FDA

Pharmaphorum

26 February 2018 - Europe’s expert medicines panel has rejected Puma Biotechnology’s breast cancer drug neratinib, citing limitations in its efficacy and safety concerns.

The rejection of neratinib on Friday by the European Medicines Agency’s CHMP didn’t come as a surprise, as Puma had warned in January that this was the likely outcome, and saw its share price plunge at the time.

But the decision is most notable because it is a rare contrast with the FDA – which approved the drug under the brand name Nerlyx last year.

Read Pharmaphorum article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Cancer , Medicine , Europe , US , Regulation