AstraZeneca gets US accelerated approval for breast cancer drug
AstraZeneca said its breast cancer drug received FDA accelerated approval, based on an FDA-authorised blood test detecting emerging ESR1 mutations tied to reduced effectiveness of current treatment. The decision follows Phase III SERENA-6 trial results.
AstraZeneca said the decision was based on an FDA-authorised blood test that detects emerging ESR1 mutations, which signal that current treatment was becoming less effective, and followed results from its Phase III SERENA-6 trial. In an interim analysis, the Etcamah combination cut the risk of disease…