Drug Approval | May 30, 2026
FDA delays AstraZeneca decision on camizestrant as regulators seek more data
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The filing is backed by results from the pivotal SERENA-6 Phase III trial
Results reinforce commitment to next-generation oral SERD development programme
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
Across more than 85 abstracts, AstraZeneca will showcase 10 approved medicines and 13 potential new therapies
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
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