14:I[94367,["/_next/static/immutable/chunks/4370mg0uq-myq.js","/_next/static/immutable/chunks/0q7ni_ir0mogv.js","/_next/static/immutable/chunks/0q9_4lzwjwc3f.js","/_next/static/immutable/chunks/1p8rnjckwz-06.js","/_next/static/immutable/chunks/3zikwth1q5z_-.js","/_next/static/immutable/chunks/0eigul57_x91p.js","/_next/static/immutable/chunks/3r0kxtkfnobr8.js","/_next/static/immutable/chunks/260mvqou7a4l3.js","/_next/static/immutable/chunks/14bkwvgoktej3.js"],"NewsDetailPage"] 15:Te42,

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor—abemaciclib, palbociclib or ribociclib—for certain adults with hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer.

The treatment is intended for patients whose tumors develop an ESR1 mutation while they are receiving an aromatase inhibitor and a CDK4/6 inhibitor. ESR1 mutations are acquired changes that can allow breast cancer cells to become resistant to endocrine therapy. While fewer than 5% of patients have these mutations when metastatic breast cancer is initially diagnosed, the proportion can rise to nearly 40% after progression on an aromatase inhibitor.

A major feature of the approval is the use of circulating tumor DNA (ctDNA). Small fragments of tumor DNA released into the bloodstream can be tested to identify ESR1 mutations before conventional imaging shows clear evidence that the cancer has progressed. The FDA described this as its first cancer therapy approval guided by detection of a resistance mutation in ctDNA before imaging-confirmed progression.

The FDA also authorized the Guardant360 CDx companion diagnostic to identify patients with ESR1-mutated breast cancer who may be eligible for camizestrant.

In the clinical trial supporting the accelerated approval, patients who switched to Etcamah while continuing a CDK4/6 inhibitor had an estimated median progression-free survival of 16 months, compared with 9.2 months for patients who continued an aromatase inhibitor with a CDK4/6 inhibitor.

Because accelerated approval can be based on an intermediate endpoint before clinical benefit is fully confirmed, the FDA has required additional confirmatory studies. These studies will determine whether detecting and treating ESR1 resistance earlier translates into a meaningful long-term benefit for patients.

The development is also relevant to India, where breast cancer remains a major cancer-care challenge and treatment decisions are increasingly influenced by molecular testing and precision oncology. The use of ctDNA to detect treatment resistance highlights the potential role of blood-based molecular testing alongside imaging and other clinical assessments.

For Indian oncology centers, wider adoption of such approaches could increase the importance of accessible genomic testing, validated companion diagnostics and multidisciplinary interpretation of molecular results. However, availability, affordability, regulatory approval and local clinical evidence will influence how quickly newer precision-oncology strategies become part of routine practice in India.

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