The US Food and Drug Administration (FDA) has officially approved AstraZeneca’s breast cancer pill camizestrant, marketed under the brand name Etcamah, despite an oncology advisory committee previously concluding that the drug didn’t provide any “meaningful benefit” to patients.
The FDA granted accelerated approval for Etcamah to be used alongside other cancer drugs for patients having metastatic breast cancer, which has been genetically driven.
As per the agency, the treatment offers women a new option to manage the disease.
Approval based on phase III trial
As per findings presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, the significant decision was supported by discoveries from the pivotal SERENA-6 Phase III trial.
Kevin Kalinsky, MD, MS, FASCO, a trial investigator, stated, “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."
Earlier this year, the FDA’s Oncology Drugs Advisory Committee voted against camizestrant, stating available evidence did not show any meaningful benefit. However, the FDA ultimately decided to approve the drug.
How Etcamah works?
Etcamah is a hormone therapy that is particularly designed to prevent estrogen to stimulate cancer cells, inhibiting their multiplication.
AstraZeneca has reported that the treatment is found to be highly-effective in delaying disease progression by over six months.
The drug is intended for patients whose tumors develop an ESR1 mutation while getting endocrine therapy.
Patients must undergo an FDA-authorized test to confirm the mutation ahead of treatment.
It is pertinent to mention Etcamah has already been approved in over 30 countries, including the European Union, Japan, Canada and the UK.
As per an estimate, the Danish drug manufacturer may generate more than $5 billion in annual sales with this drug.
Patients can access the drug by prescription and should be initiated and supervised by an oncologist.
AstraZeneca stock
Following the accomplishment of major milestone in the field of oncology, AstraZeneca's stock is trading slightly higher on the London Stock Exchange, with shares trading at 121.64 GBP.
