Puma Biotech files for EU approval of neratinib in breast cancer

USA-based Puma Biotechnology (NYSE: PBYI) said today that it has submitted its Marketing Authorization Application to the European Medicines Agency for neratinib. Notwithstanding the positive news, Puma’s shares fell 6.29% to $28.70 by mid-morning trading in the USA.

The potential indication is for the extended adjuvant treatment of HER2-positive early-stage breast cancer that has previously been treated with trastuzumab (Roche’s Herceptin)-based adjuvant therapy. The submission is based upon the ExteNET Phase III study, which reached its primary endpoint whereby neratinib demonstrated a statistically significant reduction of risk of invasive disease recurrence or death versus placebo.

"Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need for further improvement in outcome in order to attempt to further reduce this risk of recurrence following trastuzumab therapy," said Alan Auerbach, chief executive and president of Puma.