Breast Cancer

MONALEESA-7 Sets New Standard of Care for Premenopausal Advanced Breast Cancer: Adding CDK4/6 to Endocrine Therapy Extends Survival

Phoebe Starr

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - Breast Cancer

Chicago, IL—The addition of the cyclin-dependent kinase (CDK)4/CDK6 inhibitor ribociclib (Kisqali) to standard endocrine therapy significantly extended overall survival (OS) compared with endocrine therapy alone in premenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, according to results of the phase 3 MONALEESA-7 clinical trial presented at ASCO 2019. [ Read More ]

Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - Breast Cancer, FDA Approvals, News & Updates

Two human genes, BRCA1 and BRCA2 (BRCA1/2), produce proteins that block the growth of cancer, such as breast or ovarian cancer. These proteins ensure the stability of each cell’s genetic material and help to repair damaged DNA. A mutation in either BRCA results in these proteins not functioning correctly. Specifically, DNA damage may not be repaired effectively, which can lead to cancer. [ Read More ]

T-DM1 Reduces Residual Invasive Disease in Patients with HER2-Positive Breast Cancer After Chemotherapy

Phoebe Starr

June 2019, Vol 10, No 3 - Breast Cancer

The adjuvant use of the antibody-drug conjugate trastuzu­mab emtansine (T-DM1; Kadcyla) led to a clinically meaningful and significant improvement in disease-free survival versus trastuzumab (Herceptin) in patients with HER2-positive early breast cancer and residual invasive disease, despite the use of neoadjuvant chemotherapy plus HER2-targeted therapy. [ Read More ]

FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer

Breast Cancer, FDA Approvals, News & Updates, In the News

On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay). [ Read More ]

Trazimera Fourth Biosimilar to Herceptin Approved for HER2-Positive Breast Cancer or HER2-Positive Metastatic Gastric or Gastroesophageal Junction Cancer

April 2019, Vol 10, No 2 - Breast Cancer, FDA Approvals, News & Updates

On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin. [ Read More ]

Adjuvant Chemotherapy May Be Spared in Localized Breast Cancer If pCR Is Attained with Neoadjuvant Chemotherapy

Phoebe Starr

April 2019, Vol 10, No 2 - Breast Cancer

San Antonio, TX—Reaching pathologic complete response (pCR) after neo­adjuvant chemotherapy correlates with significantly improved event-free survival (EFS) and overall survival (OS) in patients with localized breast cancer, according to results of a large comprehensive meta-analysis presented at the 2018 San Antonio Breast Cancer Symposium. [ Read More ]

Tamoxifen 5 mg Daily as Effective as 20 mg in Early Localized Breast Cancer

Phoebe Starr

April 2019, Vol 10, No 2 - Breast Cancer

San Antonio, TX—The large, randomized TAM-01 clinical trial demonstrated that 5 mg daily of tamoxifen for 3 years halved the risk for recurrence of breast intraepithelial neoplasia—atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), and lobular carcinoma in situ—in women after surgery and reduced the risk for new contralateral breast cancer by 75% compared with placebo. [ Read More ]

Updated NCCN Breast Cancer Guideline Expands Treatment Recommendations for HR-Positive, HER2-Negative Disease

Wayne Kuznar

April 2019, Vol 10, No 2 - 2019 NCCN Conference, Breast Cancer

Orlando, FL—Options for the treatment of patients with advanced hormone receptor (HR)-positive, HER2­negative breast cancer are expanding. The updated National Comprehensive Cancer Network (NCCN) guideline (version 1.2019) for the management of invasive breast cancer is focused on HR-positive, HER2-negative disease. William J. Gradishar, MD, Director, Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, discussed the updated guideline at the NCCN 2019 Conference. [ Read More ]

Herceptin Hylecta a New Subcutaneous Injection Approved for Patients with HER2-Positive Breast Cancer

April 2019, Vol 10, No 2 - Breast Cancer, FDA Approvals, News & Updates

On February 28, 2019, the FDA approved a combination of the HER2/neu receptor agonist trastuzumab plus the endoglycosidase hyaluronidase-oysk (Herceptin Hylecta; Genentech) subcutaneous (SC) injection for adults with HER2-overexpressing breast cancer in the adjuvant setting, as part of a regimen with chemotherapy or as monotherapy after multimodality an­thracycline-based therapy; and as first-line treatment for metastatic disease, in combination with paclitaxel, or as monotherapy after ≥1 chemotherapies in the metastatic setting. This SC injection is a new formulation of intravenous (IV) trastuzumab. [ Read More ]