Trazimera, Pfizer's Herceptin (trastuzumab) biosimilar and their first oncology biosimilar has received approval from the European Commission. It is licensed to treat human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The approval is based on data that includes results from the REFLECTIONS B327-02 clinical comparative study, showing clinical equivalence and finding no clinically meaningful differences between Pfizer's product and the originator product in patients with first line HER2 overexpressing metastatic breast cancer. Please click here to read more on this from a PharmaTimes article.
Folllowing FDA's feedback in an end-of-Phase II meeting, Arca Biopharma plans to submit a special protocol assessment for its planned Phase III study for its beta-blocker and vasodilator Gencaro (bucindolol). The drug, which was originally developed for hypertension and heart failure but was sidelined after failing to reduce the risk of death by any cause in a 2,708-patient National Institutes of Health-sponsored study, now has FDA Fast Track Designation as a potential genetically targeted cardiovascular therapy. Please click here to read more on this from a BioPharmaDive article.