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AstraZeneca, Daiichi drug gets broad tumor approval in US

The US Food and Drug Administration cleared the medicine for patients who have HER2-positive solid tumors that have spread or can’t be removed with surgery, the company said. These patients have already received prior treatment and don’t have any good alternatives.

April 08, 2024 / 14:57 IST
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AstraZeneca, Daiichi drug gets broad tumor approval in US

AstraZeneca Plc and Daiichi Sankyo’s Enhertu has become the first drug of its kind to be granted approval to treat tumors anywhere in the body if patients test positive for a protein known to speed up cancer growth.

The US Food and Drug Administration cleared the medicine for patients who have HER2-positive solid tumors that have spread or can’t be removed with surgery, the company said. These patients have already received prior treatment and don’t have any good alternatives.

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Enhertu is the first in a promising new class of drugs called antibody drug conjugates to win such a broad clearance. These therapies deliver high medicine doses directly to tumors while minimizing damage to surrounding tissues. The field has attracted drugmakers including Pfizer Inc. and Johnson & Johnson.

Astra shares were little changed, trading at £105.50 in London.