News

Trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which is co-developed by Mylan and Biocon, has just been approved by the FDA for HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma, the same indications as trastuzumab.

The FDA has granted a priority review to a biologics license application (BLA) for mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy, according to Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody.