CHMP recommends Enhertu to treat HER2-low breast cancer
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Enhertu. The marketing authorisation holder for this medicinal product is Daiichi Sankyo Europe GmbH and licensee is AstraZeneca
The CHMP adopted a new indication for the treatment of HER2-low breast cancer.HER2-low breast cancer; Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
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