FDA Approves Fourth Trastuzumab Biosimilar

March 11, 2019 – The FDA has granted an approval to PF-05280014 (trastuzumab-qyyp), a trastuzumab biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This marks the fourth approval by the FDA for a trastuzumab biosimilar. The decision was based on findings of a comprehensive data package, including results from the phase III REFLECTIONS … (leggi tutto)