Tuesday 16/December/2025 – 05:07 PM
The Food and Drug Administration announced the approval of AstraZeneca and Daci to treat cancer the breastaccording to Reuters.
New treatment for breast cancer
Enhertu originally received US approval in late 2019 as a third-line treatment for patients with HER2-positive breast cancer.
The new authorization allows Enhertu to be used in combination with Roche’s Perjeta to treat adults with advanced HER2-positive breast cancer confirmed by an FDA-approved test.
Enhertu, which is already approved to treat certain types of breast, stomach and lung cancers, is an antibody-conjugated drug that delivers chemotherapy directly to HER2-positive cancer cells, helping to reduce damage to healthy tissue.
The success of the drug in trials
Roche’s Perjeta, developed by Genentech, was first approved in June 2012 for use in combination with trastuzumab and chemotherapy in previously treatment-naive metastatic HER2-positive breast cancer, and the US Food and Drug Administration has approved two companion diagnostic tests to identify patients with HER2-positive breast cancer who are eligible for treatment with Enhertu and Perjeta.
The approval is based on the results of a study of 1,157 patients with HER2-positive advanced breast cancer who had not received prior chemotherapy for metastatic disease.
The combination of Enhertu and Perjeta extended median progression-free survival to 40.7 months, compared to 26.9 months for standard treatment.
In the study, tumors shrank or disappeared in 87% of patients who received the new combination therapy, compared with 81% of those who received the standard treatment.
However, overall survival data were not yet mature at the time of analysis, as 16% of patients in both study groups had died.
