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HER2 Biomarkers

News and reporting on HER2 biomarkers.

The UK's Medicines and Healthcare products Regulatory Agency approved the agent together with trastuzumab and chemo based on the Phase II HER2CLIMB trial.

The test, developed at George Mason, measures HER2 activation in a breast cancer biopsy to help determine if a patient will respond to treatment.

The MHRA relied on objective response rates in previously treated, HER2-positive patients in the DESTINY-Breast01 trial to make its decision on the drug.

NICE cited uncertainties about the cost-effectiveness of Verzenio due to higher doses and longer treatment needed for patients to benefit from the drug.

Celcuity will use its CELsignia Multi-Pathway Activity Test to identify patients with hyperactive HER2 and c-MET signaling pathways.

The SOPHIA trial reported median progression-free survival of 5.8 months for HER2-positive, metastatic breast cancer patients on margetuximab.

The EMA granted conditional approval based on the drug's ability to shrink tumors in 61 percent of patients in the Phase II DESTINY-Breast01 trial.

The agency approved the new indication based on data showing that the drug improved survival in patients compared to chemotherapy.