US FDA pushes back decision on Astrazeneca's camizestrant

(Sharecast News) - Drugmaker Astrazeneca said the US Food and Drug Administration had pushed back its decision on camizestrant after requesting additional data for the drug's new application.

Astrazeneca had been seeking approval for camizestrant to be used alongside a CDK4/6 inhibitor as a first‑line treatment for patients with HR‑positive, HER2‑negative advanced breast cancer whose tumours develop an ESR1 mutation.

However, the FDA's Oncologic Drugs Advisory Committee did not reach a majority in favour of switching patients to camizestrant. AstraZeneca has since submitted further analyses requested by regulators, including new data on ctDNA clearance linked to longer‑term outcomes.

Astrazeneca's Susan Galbraith said: "We are committed to continuously advancing the clinical landscape in oncology in pursuit of improving outcomes for patients. The SERENA-6 treatment strategy epitomises this approach by monitoring patients for the emergence of ESR1 mutations in ctDNA and testing if a switch of endocrine backbone therapy at this point improves outcomes.

"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."

As of 0900 BST, Astrazeneca shares were up 0.014% at 13,962p.

Reporting by Iain Gilbert at Sharecast.com