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2:29 MD /Alert Exclusive

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Neoadjuvant Amcenestrant Shows Robust Response in Postmenopausal ER+/HER2- Breast Cancer

European Regulators Validate TNBC Biologic Treatment Application

The European Medicines Agency has validated the Marketing Authorization Application (MAA) for sacituzumab govitecan-hziy for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).

According to a release from the manufacturer, the application is specifically for patients who have had at least two prior therapies, including at least one for locally advanced or metastatic disease. The treatment is described as a “first-in-class therapy” which targets the protein Trop-2, which is seen in many types of epithelial tumors, including TNBC.

“Metastatic triple-negative breast cancer is an aggressive and life-threatening cancer,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Unfortunately, for many people with this cancer, there are not enough effective treatment options, and their prognosis is extremely poor.”

During the ASCENT trial, patients were randomized to either sacituzumab govitecan-hziy or a chemotherapy chosen by the patient’s provider. The primary endpoint of the study was progression-free survival in patients without brain meta-sta-sis at baseline.

The most common adverse reactions reported in patients with metastatic TNBC include nausea, neutropenia, diarrhea, fatigue, anemia, and vomiting.

There are currently no approved standard treatments providing benefit in overall survival for patients with previously treated metastatic TNBC, according to the release. However, the medication received accelerated approval from the FDA to treat patients with metastatic TNBC who have received at least two prior therapies for metastatic disease.

Regulatory agencies in Europe, the UK, Canada, Switzerland, and Singapore are currently reviewing applications for sacituzumab govitecan as a treatment for TNBC.

Studies are ongoing examining the treatment for patients with HR+/HER 2-negative metastatic breast cancer and metastatic non-small cell lung cancer as a monotherapy and in combination with other agents.

By Adam Hochron

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FDA Grants Fast Track Designation in HR+/HER2- Metastatic Breast Cancer

FDA Grants Fast Track Designation in HR+/HER2- Metastatic Breast Cancer

New Vaccine to Prevent Breast Cancer in Early Clinical Trials

New Vaccine to Prevent Breast Cancer in Early Clinical Trials

Therapy Targeting Inducible Nitric Oxide Signaling Shows Promise in TNBC

Therapy Targeting Inducible Nitric Oxide Signaling Shows Promise in TNBC

Trastuzumab Deruxtecan Improves Survival in HER2-Positive Breast Cancer

Trastuzumab Deruxtecan Improves Survival in HER2-Positive Breast Cancer

FDA Approves Combo of Abemaciclib, Endocrine Therapy for Early Breast Cancer

FDA Approves Combo of Abemaciclib, Endocrine Therapy for Early Breast Cancer

Atezolizumab Withdrawn from FDA Accelerated Approval for TNBC

Atezolizumab Withdrawn from FDA Accelerated Approval for TNBC

Celecoxib Shows No Benefit for Patients with Early Breast Cancer

Celecoxib Shows No Benefit for Patients with Early Breast Cancer

Research Shows Benefits of Pembrolizumab as Single Agent TNBC Treatment

Research Shows Benefits of Pembrolizumab as Single Agent TNBC Treatment

Chemotherapy Plus Treatment Combination for ERBB2-positive MBC Inferior in Clinical Practice

Chemotherapy Plus Treatment Combination for ERBB2-positive MBC Inferior in Clinical Practice

ASCO Guideline on Adjuvant Olaparib in Patients with HER2-negative Breast Cancer

ASCO Guideline on Adjuvant Olaparib in Patients with HER2-negative Breast Cancer

Durvalumab Provokes Robust Long-Term Outcomes in Patients with TNBC

Durvalumab Provokes Robust Long-Term Outcomes in Patients with TNBC

Endocrine Therapy Noninferior to Chemotherapy as First-Line Treatment for Patients with MBC

Endocrine Therapy Noninferior to Chemotherapy as First-Line Treatment for Patients with MBC

Adjuvant Olaparib Significantly Improves Invasive DFS in Patients with High-Risk EBC, BRCA Mutations

Adjuvant Olaparib Significantly Improves Invasive DFS in Patients with High-Risk EBC, BRCA Mutations

FDA Approves Sacituzumab Govitecan-hziy for Metastatic TNBC

FDA Approves Sacituzumab Govitecan-hziy for Metastatic TNBC

European Regulators Validate TNBC Biologic Treatment Application

European Regulators Validate TNBC Biologic Treatment Application

FDA Rejects Breast Cancer Therapy Due to Safety Concerns

FDA Rejects Breast Cancer Therapy Due to Safety Concerns

Large Epidemiology Study Updates Breast Cancer Risk for Women Lacking Family History

Large Epidemiology Study Updates Breast Cancer Risk for Women Lacking Family History

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

1:25 MD /Alert Exclusive

FDA Clears First Clinical Trial for Breast Cancer Vaccine

Helping Breast Cancer Oncologists Work ‘In the Trenches’

Helping Breast Cancer Oncologists Work ‘In the Trenches’

New ASCO, ASTRO, SSO Joint Clinical Guidelines for Hereditary Breast Cancer

New ASCO, ASTRO, SSO Joint Clinical Guidelines for Hereditary Breast Cancer

EU approves HER2+ Metastatic Breast Cancer Treatment

EU approves HER2+ Metastatic Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Mindfulness Shows Benefits for Young Breast Cancer

Mindfulness Shows Benefits for Young Breast Cancer

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

Study Shows Breastfeeding Can be Safe for Breast Cancer Survivors

Study Shows Breastfeeding Can be Safe for Breast Cancer Survivors

Abemaciclib Represents ‘New Standard of Care’ for Patients With High-Risk Early Breast Cancer

Abemaciclib Represents ‘New Standard of Care’ for Patients With High-Risk Early Breast Cancer

Sacituzumab Govitecan Extends Survival in Metastatic Triple-Negative Breast Cancer

Sacituzumab Govitecan Extends Survival in Metastatic Triple-Negative Breast Cancer

FDA Issues Warning Alert for Atezolizumab/Paclitaxel Combo in TNBC

FDA Issues Warning Alert for Atezolizumab/Paclitaxel Combo in TNBC

Nobel Prize Winner Links Cancer Immunotherapy to Programmed Cell Death Gene

Nobel Prize Winner Links Cancer Immunotherapy to Programmed Cell Death Gene

Neratinib and Capecitabine Improves PFS in HER2+ Metastatic Breast Cancer

Neratinib and Capecitabine Improves PFS in HER2+ Metastatic Breast Cancer

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

Featured Breast Cancer Videos

Neoadjuvant Opportunities in Early, High-Risk Breast Cancer

Neoadjuvant Opportunities in Early, High-Risk Breast Cancer

Integrating Tailored Therapy in Early, High-Risk Breast Cancer

Integrating Tailored Therapy in Early, High-Risk Breast Cancer

Providing Equitable Care in Early Breast Cancer

Providing Equitable Care in Early Breast Cancer

Going the Distance With Metastatic Breast Cancer: 'Personal Best'

Going the Distance With Metastatic Breast Cancer: "Personal Best"

Metastatic Breast Cancer: 'The Journey Begins'

Metastatic Breast Cancer: "The Journey Begins"

Breaking Research

Personalized Assay Surpasses Limits for Detecting Tumor DNA in Breast Cancer Patients

Personalized Assay Surpasses Limits for Detecting Tumor DNA in Breast Cancer Patients

Overcoming Treatment Resistance in Breast Cancer

Overcoming Treatment Resistance in Breast Cancer

Oncologist Explains How Gammapod Works for Breast Cancer

Oncologist Explains How Gammapod Works for Breast Cancer

Advancing Breast Cancer Care With Gammapod Radiation

Advancing Breast Cancer Care With Gammapod Radiation

RNA TROJAN Promotes Triple-Negative Breast Cancer Progression

RNA TROJAN Promotes Triple-Negative Breast Cancer Progression

Preventing Breast Cancer in Women Carrying BRCA1 Gene

Preventing Breast Cancer in Women Carrying BRCA1 Gene

ASCO 2023 Annual Meeting

Donepezil Does Not Improve Cancer-Related Cognitive Impairment in Breast Cancer Survivors

Donepezil Does Not Improve Cancer-Related Cognitive Impairment in Breast Cancer Survivors

Breast Cancer Index Risk Scores a Prognostic Indicator of Overall, Late Distant Recurrence

Breast Cancer Index Risk Scores a Prognostic Indicator of Overall, Late Distant Recurrence

HER3-DXd Promotes Clinical Activity in MBC at Varying HER3 Expression Levels

HER3-DXd Promotes Clinical Activity in MBC at Varying HER3 Expression Levels

Capecitabine Has Less Toxicity, Similar Survival in Metastatic Breast Cancer with Fixed Dose

Capecitabine Has Less Toxicity, Similar Survival in Metastatic Breast Cancer with Fixed Dose

Greater Weight Loss Among Women with Breast Cancer After Phone-Based Coaching

Greater Weight Loss Among Women with Breast Cancer After Phone-Based Coaching

Curated For You

Genomic Profiling Improves Metastatic Breast Cancer Research

Genomic Profiling Improves Metastatic Breast Cancer Research

New Uses for Existing Therapies in Breast Cancer Research

New Uses for Existing Therapies in Breast Cancer Research

Various Breast Cancer Research Challenges in Recurrence, Triple Negative BC

Various Breast Cancer Research Challenges in Recurrence, Triple Negative BC

Understanding Recent Breast Cancer Vaccine Breakthroughs

Understanding Recent Breast Cancer Vaccine Breakthroughs

Study of Immunotherapy Combinations for Patients with Metastatic Breast Cancer

Study of Immunotherapy Combinations for Patients with Metastatic Breast Cancer

Why Dual Light Therapy Hits Triple Negative Breast Cancer Harder

Why Dual Light Therapy Hits Triple Negative Breast Cancer Harder

Improving Outcomes for Early Onset Breast Cancer

Improving Outcomes for Early Onset Breast Cancer

SABCS 2022 Annual Meeting

Capivasertib, Fulvestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Capivasertib, Fulvestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Camizestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Camizestrant Improves PFS in Patients with HR+/HER2– Breast Cancer

Trastuzumab Deruxtecan Significantly Improves OS, PFS in Patients with MBC

Trastuzumab Deruxtecan Significantly Improves OS, PFS in Patients with MBC

Ribociclib, Endocrine Therapy Combination Improves PFS in Aggressive Breast Cancer

Ribociclib, Endocrine Therapy Combination Improves PFS in Aggressive Breast Cancer

ASCO 2022 Annual Meeting

FDA Approves Trastuzumab Deruxtecan for HER2-Low Breast Cancer

FDA Approves Trastuzumab Deruxtecan for HER2-Low Breast Cancer

European Commission Approves Trastuzumab Deruxtecan for Second-Line HER2+ Breast Cancer

European Commission Approves Trastuzumab Deruxtecan for Second-Line HER2+ Breast Cancer

Treatment Combination Shows Promise in HR+, HER2–, HER2-mutant Metastatic Breast Cancer

Treatment Combination Shows Promise in HR+, HER2–, HER2-mutant Metastatic Breast Cancer

Zanidatamab-Docetaxel Effective as First-Line Therapy in Advanced HER2+ Breast Cancer

Zanidatamab-Docetaxel Effective as First-Line Therapy in Advanced HER2+ Breast Cancer

Sacituzumab Govitecan Safe and Effective in Patients 65 and Older with TNBC

Sacituzumab Govitecan Safe and Effective in Patients 65 and Older with TNBC

Palbociclib Combination Fails to Extend Overall Survival for Advanced Breast Cancer

Palbociclib Combination Fails to Extend Overall Survival for Advanced Breast Cancer

Trastuzumab Deruxtecan Highly Effective in Patients with HER2-Low Metastatic Breast Cancer

Trastuzumab Deruxtecan Highly Effective in Patients with HER2-Low Metastatic Breast Cancer

Clinical Trials Need Better Representation Among Black Patients

Clinical Trials Need Better Representation Among Black Patients

SABCS 2020 Annual Meeting

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

FDA Committee Delays Approval of Pembrolizumab for Early TNBC

1:25 MD /Alert Exclusive

FDA Clears First Clinical Trial for Breast Cancer Vaccine

Helping Breast Cancer Oncologists Work ‘In the Trenches’

Helping Breast Cancer Oncologists Work ‘In the Trenches’

EU approves HER2+ Metastatic Breast Cancer Treatment

EU approves HER2+ Metastatic Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Studies Emphasizes Need for Universal Testing in Breast Cancer Treatment

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Impassion031 Outcomes Show Importance of Looking Beyond Initial Trial Data

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Combination Therapy Fails to Meet Primary Endpoints in HR+ HER2- Breast Cancer Treatment

Mindfulness Shows Benefits for Young Breast Cancer

Mindfulness Shows Benefits for Young Breast Cancer

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Time to Treatment Completion Associated with Poor Breast Cancer Survival

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

Neratinib + Capecitabine Improves QoL for HER2+ Metastatic Breast Cancer

ASCO 2020 Annual Meeting

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

MINDACT Study Shows Continued Success in Determining Chemotherapy Usage

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Pembrolizumab + Chemotherapy Beneficial in Triple-Negative Breast Cancer

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

Advanced ER+ HER2+ Breast Cancer Combo Therapy Fails to Improve Outcomes

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

HER2CLIMB Study Shows Benefits of Triple Therapy for HER2+ Metastatic Breast Cancer with Brain Metastases

Study Shows Tolerable Safety of Abemaciclib Plus Pembrolizumab in HER2-, Metastatic Breast Cancer

Study Shows Tolerable Safety of Abemaciclib Plus Pembrolizumab in HER2-, Metastatic Breast Cancer

Combining Eribulin and Pembrolizumab in Metastatic Triple-Negative Breast Cancer

Combining Eribulin and Pembrolizumab in Metastatic Triple-Negative Breast Cancer