Advisory Panel Recommends Approval of Vysis HER2 Test

Combining tucatinib with ado-trastuzumab emtansine does not appear to result in any new safety signals in the treatment of those with locally advanced or metastatic HER2-positive breast cancer.

As part of our coverage for the 30th Annual Miami Breast Cancer Conference, we bring you an interview with Dr. Mark Pegram, director of the breast cancer program at the Stanford Women’s Cancer Center and codirector of the molecular therapeutics program. Dr. Pegram will be discussing the potential for novel HER2 combination therapies at the conference.

Hospitalization rates appear to be comparable between patients receiving trastuzumab deruxtecan and trastuzumab emtansine for HER2-positive breast cancer in the phase 3 DESTINY-Breast03 study.

To kick off SABCS 2012, we discuss the use of molecular testing for the diagnosis and treatment of breast cancer patients in the clinical setting with Dr. Antonio Wolff of the Kimmel Cancer Center at Johns Hopkins University, one of the presenter's during the "Practical Use of Molecular Profiling" session at this year's symposium.

The FDA requests additional information requiring time and resources extending beyond the current evaluation period for vic-trastuzumab duocarmazine in advanced HER2-positive breast cancer.

Supporting data for the biologics license application for trastuzumab biosimilar HLX02 in HER2-overexpressing cancers come from comparative analytical studies and a global phase 3 trial.