AstraZeneca: Enhertu gets breakthrough therapy status
(CercleFinance.com) - AstraZeneca announced on Monday that the Food and Drug Administration (FDA) has granted breakthrough therapy status to Enhertu for the treatment of breast cancer.
The biopharmaceutical company said the decision by the US health authority applies to adult patients with inoperable or metastasised HER2-positive cancer who have already received one or more treatments.
This is the fourth breakthrough therapy designation obtained by Enhertu from the FDA following similar decisions in lung cancer and stomach cancer, amongst others.
Enhertu, developed with Japan's Daiichi Sankyo, consists of a monoclonal antibody, making it an immunotherapy treatment.
For the record, a breakthrough therapy designation aims to accelerate the development and regulatory evaluation of drugs to treat serious diseases.
Copyright (c) 2021 CercleFinance.com. All rights reserved.
The biopharmaceutical company said the decision by the US health authority applies to adult patients with inoperable or metastasised HER2-positive cancer who have already received one or more treatments.
This is the fourth breakthrough therapy designation obtained by Enhertu from the FDA following similar decisions in lung cancer and stomach cancer, amongst others.
Enhertu, developed with Japan's Daiichi Sankyo, consists of a monoclonal antibody, making it an immunotherapy treatment.
For the record, a breakthrough therapy designation aims to accelerate the development and regulatory evaluation of drugs to treat serious diseases.
Copyright (c) 2021 CercleFinance.com. All rights reserved.