Roche’s immunotherapy drug Tecentriq was approved in the United States for treatment of patients suffering from triple negative breast cancer (TNBC), which is a progress in fight with this aggressive disease.
The FDA approved Tecentriq in combination with a chemotherapeutic drug Abraxane for the treatment of inoperable locally advanced or metastatic TNMP in patients with PD-L1 protein expression.
In a study conducted by Roche, approximately 40% of patients had tumors with a high level of PD-L1 expression.
The FDA approved this combination of drugs based on clinical study showed a slower progression of the disease by 7.4 months (median value) compared with 4.8 months when chemotherapy was used alone.
Roche is still awaiting data on overall survival and its specialists noted that positive opinion of a regulator may depend on results of further supporting studies.
According to Roche Medical Director Sandra Horning, the Tecentriq combination is one of the first cancer immunotherapy regimens approved for breast cancer and symbolizes significant progress in understanding this disease.