FDA Delays Decision on AstraZeneca Breast Cancer Pill

FDA delays decision on AstraZeneca breast cancer pill

The review extension comes weeks after an advisory panel found the evidence supporting the drug, camizestrant, inconclusive in what would be a new kind of treatment setting.

Pharmalittle: We're reading about an AstraZeneca breast cancer pill, an ADAP deal in Florida, and more

Brazil approved its first generic version of Ozempic, opening the door to cheaper competition in a fast-growing market for obesity drugs.

FDA delays verdict on AZ breast cancer drug

After an advisory committee setback, AstraZeneca has a chance to make the case for its oral SERD camizestrant for breast cancer.

AstraZeneca breast cancer pill faces review delay from regulators

FDA Pushes Back Review Deadline For AstraZeneca's Camizestrant Breast Cancer Drug Application

AstraZeneca (AZN) has been informed by the FDA that it will extend the PDUFA date to review additional data related to the New Drug Application for camizestrant. The drug is being reviewed for use in combination with a cyclin-dependent kinase 4/6 inhibitor as a first-line treatment option. The targeted patient group consists of those with hormone receptor-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation.…

US FDA extends review of AstraZeneca’s experimental breast cancer pill

May 27 (Reuters) – AstraZeneca said on Wednesday the U.S. Food and Drug Administration has extended the decision deadline ​for the drugmaker’s experimental breast cancer ‌pill camizestrant to review additional data. The delay comes after a majority of the FDA’s advisory panel in April voted against the drug in combination ‌with ​another type of therapy ⁠known as CDK4/6 ⁠inhibitor, due to concerns about the design of a key late-stage trial rather…