AstraZeneca’s breast cancer pill wins US approval in accelerated process

The US Food and Drug Administration (FDA) has approved AstraZeneca’s breast cancer pill camizestrant, despite the agency’s oncology advisory committee previously concluding that the drug offered no “meaningful benefit” to patients.

The medication, which will be marketed under the brand name Etcamah, received accelerated approval for use in combination with other cancer medicines in patients with a genetically driven form of metastatic breast cancer, as US media outlets report.

Earlier this year, the FDA’s Oncology Drugs Advisory Committee voted against camizestrant, determining that the available evidence did not demonstrate a “meaningful benefit” for patients. In granting approval, however, the FDA said the medication would provide women with breast cancer with an additional treatment option.

The approval was based on findings from the pivotal SERENA-6 Phase III trial, which were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine.

Kevin Kalinsky, MD, MS, FASCO, Division Director of Medical Oncology at the Winship Cancer Institute of Emory University and an investigator on the trial, said: “The combination provides an important new option for the one in three patients with this form of advanced breast cancer whose tumors develop ESR1 mutations before clinical or radiographic disease progression."

"Today’s approval will enable clinicians to promptly intervene and change therapeutic strategy at an earlier opportunity ahead of disease progression, rather than waiting until the cancer becomes harder to treat, and patient outcomes and quality of life worsen," Kalinsky said.

AstraZeneca has said the drug could eventually generate more than $5 billion in annual sales.

Etcamah works as a hormone therapy by preventing estrogen from stimulating cancer cells, helping to slow their growth. AstraZeneca has reported that the pill can delay disease progression by more than six months.

The drug is intended for patients whose breast cancer has developed a specific mutation known as ESR1 during treatment with endocrine therapy. Before receiving Etcamah, patients will need an FDA-authorized test confirming that they have the mutation.

The medication has also been approved in more than 30 countries, including the European Union, Japan, Canada and the UK.

Etcamah is available only by prescription, and treatment should be initiated and supervised by a doctor experienced in administering cancer medicines.

By Nazrin Sadigova