US FDA approves AstraZeneca, Daiichi's breast cancer drug as first-line treatment

The US Food and Drug Administration has approved Daiichi Sankyo's therapy in combination with Roche's drug for the first-line treatment of patients with a type of breast cancer, the regulator said on Monday.

The drug, sold under the brand name Enhertu, co-developed by Daiichi Sankyo and AstraZeneca, originally won US approval in late 2019 as a third-line treatment for HER-2-positive breast cancer patients.

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The new approval allows the use of Enhertu with Roche's Perjeta to treat adults with advanced HER2-positive breast cancer confirmed by an FDA-approved test.