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.

Adjuvant therapy is associated with high toxicity and most patients will derive no benefit, Umberto Capitanio, MD, San Raffaele Scientific Institute, Milan, Italy, said in a presentation during the 2017 EMUC Congress. However, adjuvant therapy “might show the highest ratio between clinical benefit and toxicity” in this specific subset of high-risk patients.

“Are there ways that we can optimize the cure rates with HIFU? When are people recurring? What are we missing when they recur? What are the true rates of complications? We do not know the answer to most of these questions,” says Jonathan Warner, MD.