06.03.2013 - Swiss Roche has gotten EU approval for Perjeta (pertuzumab). The antibody boosts efficacy of Herceptin by blocking HER dimerisation.
The European Commission gave the green light for a combination therapy of pertuzumab, Herceptin (trastuzumab) and docetaxel in previously untreated adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer. The recommendation for market approval is based on Roche’s Phase III CLEOPATRA study in which the combination therapy prolonged median progression-free survival for 6.1 months compared to Herceptin and chemotherapy alone. Furthermore, the treatment triggered a 34% reduction in the risk of death.
The improvement of Herceptin efficacy by Perjeta is due to a synergistic mode of action of the two antibody drugs. Herceptin blocks homodimerisation of HER2 when HER2 is overexpressed. The antibody prevents activation of HER2-dependent pathways by binding to the extracellular domain IV of the protein and thus blocks MAPK-dependent cell proliferation and PI3K-dependent inhibition of apoptosis. In contrast, Perjeta binds HER2 from the opposite side and prevents heterodimerisation with HER1 and HER3 proteins. Especially, inhibition of HER2/HER3 dimerisation seems important as HER3 supports PI3K-mediated cell proliferation following dimerisation with HER2.
“The EU approval of Perjeta is the result of years of research into the HER2 pathway and we are excited to offer a new treatment option for people with this aggressive disease,” said Roche’s CMO Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. The combination therapy provides a clever strategy for extension of Herceptin’s life cycle. However, Roche is already evaluating a combination therapy of its antibody-toxin warhead T-DM1 with Perjeta.
15.09.2014 Jean Claude Juncker, the European Commission President-elect revealed his new Commissioners last week, whilst announcing a change in the units dealing with medicines, medical devices and health technology.
12.09.2014 The 2011 collaboration of Boehringer Ingelheim and Eli Lilly is bearing fruit. An insulin biosimilar developed through the partnership has now been approved in Europe - the first-ever generic version of this class.
09.09.2014 In the midst of the hustle and bustle of the European Respiratory Society’s International Congress 2014, Astrazeneca quietly announced the disappointing results of its latest benralizumab study.
29.08.2014 Just a week ago, Glaxosmithkline defused the WHO’s claim that an Ebola vaccine could be ready by 2015. Now, the British company’s own candidate vaccine is to be rushed to human trials with the help of funding from an international consortium.