HER2-Positive Breast Cancer

FDA Approves New VENTANA HER2 Dual ISH DNA Probe Cocktail Assay for Detection of HER2
July 29, 2020
ByHannah Slater

In addition to being approved to detect the HER2 biomarker in breast cancer, the assay was approved as a companion diagnostic for trastuzumab therapy.

FDA Grants Fast Track Designation to BDTX-189 to Treat Allosteric HER2 or EGFR Mutations
July 28, 2020
ByMatthew Fowler

Black Diamond Therapeutics announced that the FDA granted fast track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20 insertion mutation.

FDA Approves Phesgo for Injection to Treat Adults with HER2+ Breast Cancer
June 29, 2020
ByHannah Slater

The FDA approved phesgo for injection under the skin to treat adult patients with early and metastatic HER2-positive breast cancer.