The U.S. Food and Drug Administration (FDA) has granted accelerated approval to camizestrant (Etcamah) in combination with a CDK4/6 inhibitor for certain adults with hormone receptor-positive (HR+), HER2-negative, locally advanced or metastatic breast cancer with an ESR1 mutation detected during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
The approval, granted on September 4, 2026, was based on findings from the SERENA-6 clinical trial, which evaluated switching to camizestrant upon detection of an ESR1 mutation before radiographic disease progression. The FDA reported an estimated median progression-free survival of 16 months with camizestrant plus a CDK4/6 inhibitor compared with 9.2 months with continued aromatase inhibitor plus a CDK4/6 inhibitor. The approval was granted under the FDA's accelerated approval pathway, with confirmatory studies required to verify and describe clinical benefit.
NHO Revive is also contributing to the broader clinical research of camizestrant through prior conduct of the SERENA-2 study, as well as ongoing participation in the active studies like CAMBRIA-1 and CAMBRIA-2. These trials are evaluating camizestrant in other disease settings among patients with HR-positive, HER2-negative breast cancer, including advanced and early breast cancer. While these are separate from SERENA-6, they reflect continued research into the potential role of camizestrant across different settings of breast cancer.
NHO Revive remains committed to supporting clinical research and providing eligible patients with opportunities to participate in clinical trials evaluating investigational therapies.
