FDA grants Enhertu tumor-agnostic accelerated approval
05 Apr 2024
ADCDrug ApprovalAccelerated Approval
The FDA on Friday gave Daiichi Sankyo and AstraZeneca’s antibody-drug conjugate Enhertu a tumor-agnostic indication under accelerated approval. It’s the first such approval for a HER2-directed therapy — and the first antibody-drug conjugate to get a tumor-agnostic indication from the FDA.
The FDA approved Enhertu for adults with advanced HER2-positive solid tumors who have received prior systemic treatment and have no good options left. The blockbuster antibody-drug conjugate was previously approved for certain breast cancer, lung cancer and stomach cancer patients.
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Source: EndPoints
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