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The US Food and Drug Administration granted accelerated approval on 4 September 2026 to AstraZeneca's Etcamah (camizestrant) for advanced or metastatic HR-positive, HER2-negative breast cancer carrying an ESR1 mutation.
It is a 75 mg oral daily therapy used in combination with the CDK4/6 inhibitors abemaciclib, palbociclib or ribociclib.
It is the first cancer therapy approved on the basis of a resistance mutation detected in circulating tumour DNA before the disease shows progression on imaging.
The FDA simultaneously approved Guardant Health's Guardant360 CDx as the companion diagnostic for detecting qualifying ESR1 mutations.
In the 315-patient Phase III SERENA-6 trial, median progression-free survival was 16.0 months against 9.2 months on standard aromatase inhibitor therapy.
The United States regulator for drugs, biologics, medical devices and food. Its accelerated approval pathway clears drugs for serious conditions with unmet need on the basis of a surrogate endpoint, subject to confirmatory evidence.
An external expert advisory committee to the FDA on cancer drugs. Its 6-3 vote against the early-switching strategy in April 2026 did not bind the agency - ODAC advice is recommendatory, and the FDA approved the drug regardless.
Anglo-Swedish pharmaceutical company that developed camizestrant; its Oncology Business Unit is headed by Executive Vice President Dave Fredrickson.
Developer of the Guardant360 CDx liquid-biopsy assay approved as the companion diagnostic for this therapy.
Dying tumour cells shed DNA fragments into the bloodstream. Sequencing that plasma DNA - a liquid biopsy - reveals a tumour's mutations from a blood draw, without cutting tissue, and can catch a resistance mutation weeks before a scan shows the tumour growing.
Simple Analogy: Reading a factory's output from the debris in its drain, without entering the building.
GS Paper III > Science and Technology: biotechnology, health
General Science > Biology and current science affairs
The gene encoding the oestrogen receptor; acquired mutations in it cause resistance to aromatase inhibitor therapy.
A US FDA pathway that clears drugs for serious conditions with unmet need on surrogate endpoints, subject to confirmatory trials.
The time from treatment start until the disease worsens or the patient dies - a standard oncology trial endpoint.