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First immunotherapy drug to treat breast cancer approved by FDA


Headquarters of the Swiss multinational healthcare company Roche. (Rafael_Wiedenmeier / Getty Images)

The first-ever immunotherapy treatment for breast cancer has been approved by the Food and Drug Administration.

Tecentriq, from Swiss drug company Roche, is designed to treat triple-negative breast cancer, an aggressive disease “with high unmet medical need,” according to a release from the brand.

In triple-negative breast cancer — which applies to 10% to 20% of breast cancer cases, according to — the cancer growth is not sparked by the hormones estrogen and progesterone, or by the HER2 protein, so it doesn’t respond to hormonal therapy medicines or drugs that target HER2 protein receptors.

Tecentriq was signed off on under the FDA’s Accelerated Approval Program, which allows for a speedy approval of drugs that treat serious conditions and that fill an unmet medical need.

Immunotherapy treats diseases by activating or suppressing the immune system. The drug is meant to work in combination with other targeted medicines and chemotherapies. It has already been approved in the U.S. and dozens of other countries to treat certain kinds of lung cancers and carcinomas.

“This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease,” Sandra Horning, Roche’s chief medical officer and head of global product development, said in a statement.