Nisha Pandey

FDA Approves New Breast Cancer Treatment That Targets Resistance Before Cancer Progresses

The US Food and Drug Administration has approved a new <span>breast <a href="https://www.healthandme.com/health/cancer">cancer</a> treatment</span> that aims to act on signs of treatment resistance before the <span>cancer</span> starts progressing.

The US FDA has granted accelerated approval to Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic <span><a href="https://www.healthandme.com/health/breast-cancer">breast cancer</a></span> whose tumours develop an ESR1 mutation while being treated with an aromatase inhibitor and a CDK4/6 inhibitor.

<h2>All About The New Breast Cancer Treatment </h2>

<a href="https://www.healthandme.com/health-news/how-scientists-blocked-drug-resistant-triple-negative-breast-cancer-with-a-two-step-drug-method-article-156024315" data-type="tilCustomLink">ESR1 mutations</a> can make hormone therapy less effective. They may emerge while a patient is still responding to treatment and before scans shows that the cancer has progressed.

The new approach uses a blood test to detect circulating tumour DNA (ctDNA) carrying an ESR1 mutation. If the mutation is detected, doctors can switch treatment to camizestrant rather than waiting for visible disease progression on scans.

The FDA described this as its first cancer therapy approval guided by detection of a resistance mutation in circulating tumour DNA before imaging shows progression of the disease.

Also read: <a href="https://www.healthandme.com/health-wellness/have-dense-breasts-what-women-should-know-about-their-breast-cancer-risk-article-156045857" data-type="tilCustomLink">Have Dense Breasts? What Women Should Know About Their Breast Cancer Risk</a>

<h2>What Did The Clinical Trial Find?</h2>

The approval was based on results from the <a href="https://www.healthandme.com/health-news/melatonin-or-insomnia-scientists-question-90-higher-heart-failure-risk-linked-to-long-term-use-of-the-supplement-article-156014590" data-type="tilCustomLink">Phase III SERENA-6 trial</a>, which included 315 patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.

All participants were receiving an aromatase inhibitor plus a CDK4/6 inhibitor as their initial endocrine based treatment and had no evidence of disease progression when an ESR1 mutation was detected through blood testing. 

Patients were randomly assigned to either switch to camizestrant while continuing their CDK4/6 inhibitor or continue their existing aromatase inhibitor with the CDK4/6 inhibitor.

Survival period without progression was 16 months with camizestrant compared with 9.2 months with standard treatment. The risk of disease progression or death was reduced by 56% with the camizestrant combination. 

<a href="https://www.healthandme.com/health-news/french-court-links-flight-attendants-breast-cancer-to-workplace-radiation-how-does-flying-increase-cancer-risk-article-155995063" data-type="tilCustomLink">AstraZeneca</a> reported that a later planned analysis also showed a benefit in time to second disease progression, with median PFS2 of 25.7 months versus 19.1 months.

Also read: <a href="https://www.healthandme.com/health-news/alcohol-linked-cancer-deaths-doubled-in-us-colorectal-leads-in-men-breast-leads-in-women-article-156041001" data-type="tilCustomLink">Alcohol-Linked Cancer Deaths Doubled In US: Colorectal Leads In Men, Breast Leads In Women</a> 

<h2>Importance Of <span rel="noindex">ESR1 Mutations</span></h2>

ESR1 mutations are one way hormone receptor-positive breast cancers can adapt to treatment. According to the FDA, fewer than 5% of patients have an ESR1 mutation when HR-positive <a href="https://www.healthandme.com/health-news/is-there-a-link-between-birth-control-and-breast-cancer-studies-suggest-article-151007103" data-type="tilCustomLink">metastatic breast cancer</a> is first diagnosed. After disease progression on an aromatase inhibitor, however, the mutation is found in nearly 40% of patients.

This means that detecting the mutation earlier could potentially give doctors a chance to change treatment while the cancer is still controlled.

Dr Kevin Kalinsky, an investigator on SERENA-6, said, "The approach allows doctors to change treatment at an earlier opportunity ahead of disease progression rather than waiting until the cancer becomes harder to treat."

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The FDA approval is accelerated, meaning continued approval may depend on confirmatory studies that will verify clinical benefit. 

The regulator specifically noted that it has not yet been established whether intervening when an ESR1 mutation is detected, before radiographic progression, ultimately translates into a meaningful overall survival benefit. 

<a href="https://www.healthandme.com/health-wellness/at-31-new-mom-diagnosed-with-terminal-breast-cancer-weeks-after-mammogram-showed-no-tumor-shares-missed-warning-signs-article-151465868" data-type="tilCustomLink">Camizestrant</a> also carries important safety warnings. Its prescribing information includes a boxed warning about heart-rhythm abnormalities, along with warnings about slow heart rate and potential harm to an unborn baby.

The FDA has simultaneously approved the Guardant360 CDx blood test as a companion diagnostic to identify patients whose tumours carry the relevant ESR1 mutations. 

The significance of the approval therefore goes beyond a new drug. It represents a shift toward using molecular clues in the bloodstream to detect treatment resistance and change therapy before cancer progression becomes visible on a scan.

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AstraZeneca

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The US Food and Drug Administration has approved a new breast cancer treatment that aims to act on signs of treatment resistance before the cancer starts progressing.The US FDA has granted accelerated approval to Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose tumours develop an ESR1 mutation while being treated with an aromatase inhibitor and a CDK4/6 inhibitor.All About The New Breast Cancer Treatment ESR1 mutations can make hormone therapy less effective. They may emerge while a patient is still responding to treatment and before scans shows that the cancer has progressed.The new approach uses a blood test to detect circulating tumour DNA (ctDNA) carrying an ESR1 mutation. If the mutation is detected, doctors can switch treatment to camizestrant rather than waiting for visible disease progression on scans.The FDA described this as its first cancer therapy approval guided by detection of a resistance mutation in circulating tumour DNA before imaging shows progression of the disease.Also read: Have Dense Breasts? What Women Should Know About Their Breast Cancer RiskWhat Did The Clinical Trial Find?The approval was based on results from the Phase III SERENA-6 trial, which included 315 patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.All participants were receiving an aromatase inhibitor plus a CDK4/6 inhibitor as their initial endocrine based treatment and had no evidence of disease progression when an ESR1 mutation was detected through blood testing. Patients were randomly assigned to either switch to camizestrant while continuing their CDK4/6 inhibitor or continue their existing aromatase inhibitor with the CDK4/6 inhibitor.Survival period without progression was 16 months with camizestrant compared with 9.2 months with standard treatment. The risk of disease progression or death was reduced by 56% with the camizestrant combination. AstraZeneca reported that a later planned analysis also showed a benefit in time to second disease progression, with median PFS2 of 25.7 months versus 19.1 months.Also read: Alcohol-Linked Cancer Deaths Doubled In US: Colorectal Leads In Men, Breast Leads In Women Importance Of ESR1 MutationsESR1 mutations are one way hormone receptor-positive breast cancers can adapt to treatment. According to the FDA, fewer than 5% of patients have an ESR1 mutation when HR-positive metastatic breast cancer is first diagnosed. After disease progression on an aromatase inhibitor, however, the mutation is found in nearly 40% of patients.This means that detecting the mutation earlier could potentially give doctors a chance to change treatment while the cancer is still controlled.Dr Kevin Kalinsky, an investigator on SERENA-6, said, "The approach allows doctors to change treatment at an earlier opportunity ahead of disease progression rather than waiting until the cancer becomes harder to treat."         Risks And LimitationsThe FDA approval is accelerated, meaning continued approval may depend on confirmatory studies that will verify clinical benefit. The regulator specifically noted that it has not yet been established whether intervening when an ESR1 mutation is detected, before radiographic progression, ultimately translates into a meaningful overall survival benefit. Camizestrant also carries important safety warnings. Its prescribing information includes a boxed warning about heart-rhythm abnormalities, along with warnings about slow heart rate and potential harm to an unborn baby.The FDA has simultaneously approved the Guardant360 CDx blood test as a companion diagnostic to identify patients whose tumours carry the relevant ESR1 mutations. The significance of the approval therefore goes beyond a new drug. It represents a shift toward using molecular clues in the bloodstream to detect treatment resistance and change therapy before cancer progression becomes visible on a scan.

fda approves new breast cancer treatment that targets resistance before cancer progresses

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