AstraZeneca's experimental breast cancer pill, camizestrant (to be marketed as Etcamah), received a backing for approval from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday. This positive opinion recommends approval for adults with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of an ESR1 mutation, to be used in combination with a CDK4/6 inhibitor without disease progression during first-line endocrine therapy. The decision is based on data from the Phase 3 SERENA-6 trial, which showed the drug, in combination with other cancer medicines, reduced the risk of cancer progression or death by 56%, extending disease control to an average of 16 months compared to just over 9 months with standard treatment.
This decision stands in stark contrast to an April 30 vote by the U.S. FDA’s Oncology Drugs Advisory Committee (ODAC), which voted 6-3 against the treatment. The FDA panel raised concerns primarily about the design of the key late-stage trial, rather than the drug's safety or effectiveness. While the FDA typically follows the advice of its expert committees, it is not bound to do so. AstraZeneca stated that discussions with U.S. regulatory authorities are ongoing and additional trial data will be presented at a medical conference this month.
The EU backing is a significant step for AstraZeneca, which anticipates camizestrant could generate more than $5 billion in peak annual sales. It is one of 20 new medicines the Anglo-Swedish drugmaker expects to launch by 2030 to achieve its $80 billion revenue target. Susan Galbraith, a senior executive at AstraZeneca, expressed pleasure that the CHMP recognized the value of their monitoring approach and emphasized the company's commitment to working with various countries for access after official approval from the European Commission.
Separately, AstraZeneca's Enhertu also received a CHMP recommendation for approval in the EU as a monotherapy for previously treated HER2-positive metastatic solid tumors, potentially making it the first HER2-directed therapy with a tumor-agnostic indication in Europe. In the U.S., the FDA approved Datroway for first-line treatment for metastatic triple-negative breast cancer. These concurrent regulatory successes highlight AstraZeneca's broad pipeline in oncology.
