MedCity News April 8, 2024
The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.
The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body.
Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors....
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