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 […]
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US FDA extends review of AstraZeneca’s experimental breast cancer pill
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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 than its safety or efficacy.
The Anglo-Swedish drugmaker said it has submitted additional analyses requested by the FDA to support its new drug application, including data linked to longer-term efficacy outcomes that will be presented at a conference on June 2.
“We look forward to continuing the dialogue with the FDA in order to bring the benefits of camizestrant with this innovative treatment strategy to eligible patients in the US as quickly as possible,” said Susan Galbraith, a senior executive at AstraZeneca, in a statement.
AstraZeneca’s camizestrant pill is designed for patients with a type of breast cancer in which tumours carry a specific mutation.
Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of the drug.
(Reporting by Ankita Bora in Bengaluru; Editing by Nivedita Bhattacharjee)