Stay up to date with notifications from The IndependentNotifications can be managed in browser preferences.Jump to contentThank you for registeringPlease refresh the page or navigate to another page on the site to be automatically logged inPlease refresh your browser to be logged inAllNewsSportCultureLifestyleThe US Food and Drug Administration (FDA) has extended its review period for AstraZeneca's experimental breast cancer pill, camizestrant, to scrutinise additional data. This delay follows an April vote by the FDA advisory panel against the drug when used in combination with a CDK4/6 inhibitor, citing concerns over the design of a vital late-stage trial rather than safety or efficacy. AstraZeneca has submitted further analyses, including longer-term efficacy outcomes, as requested by the FDA to support its new drug application. Camizestrant is designed for patients with a specific breast cancer characterised by tumors carrying a particular mutation.The FDA's delayed decision comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of the drug last week.In fullAstraZeneca’s ‘game changer’ cancer pill stuck in limbo as FDA demands more dataThank you for registeringPlease refresh the page or navigate to another page on the site to be automatically logged inPlease refresh your browser to be logged in
AstraZeneca breast cancer pill faces review delay from regulators
Stay up to date with notifications from The IndependentNotifications can be managed in browser preferences.Jump to contentThank you for registeringPlease refresh the page or navigate to another page on the site to be automatically logged inPlease refresh your browser to be logged inAllNewsSportCultureLifestyleThe US Food and Drug Administration (FDA) has extended its review period for AstraZeneca's experimental breast cancer pill, camizestrant, to scrutinise additional data. This delay follows an April vote by the FDA advisory panel against the drug when used in combination with a CDK4/6 inhibitor, citing concerns over the design of a vital late-stage trial rather than safety or efficacy. AstraZeneca has submitted further analyses, including longer-term efficacy outcomes, as requested by the FDA to support its new drug application. Camizestrant is designed for patients with a specific breast cancer characterised by tumors carrying a particular mutation.The FDA's delayed decision comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of the drug last week.In fullAstraZeneca’s ‘game changer’ cancer pill stuck in limbo as FDA demands more dataThank you for registeringPlease refresh the page or navigate to another page on the site to be automatically logged inPlease refresh your browser to be logged in
