Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation
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.
FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
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).
T-DM1 Reduces Residual Invasive Disease in Patients with HER2-Positive Breast Cancer After Chemotherapy
Adding the PD-L1 inhibitor atezolizumab (Tecentriq) to nab-paclitaxel (Abraxane) chemotherapy is the first immunotherapy-based combination to improve progression-free survival (PFS) and overall survival (OS) in women with advanced or metastatic triple-negative breast cancer and PD-L1 expression compared with placebo plus nab-paclitaxel, according to results of the IMpassion130 clinical trial.
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
Recent results with the investigational targeted therapy alpelisib, a PI3K inhibitor, showed impressive clinical benefits. Adding alpelisib to fulvestrant (Faslodex) extended progression-free survival (PFS) compared with endocrine therapy alone in patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer characterized by a PIK3CA mutation.
Less Is More: 6 Months of Trastuzumab Treatment Equivalent to 12 Months in HER2-Positive Breast Cancer
Chicago, IL—The current standard of care for women with early, HER2-positive breast cancer is 12 months of trastuzumab (Herceptin). Analysis of the phase 3 randomized clinical trial PERSEPHONE showed that 6 months of treatment with trastuzumab was noninferior to 12 months in terms of disease-free survival.
A new study presented at the 2018 American Association for Cancer Research meeting suggests that HER2 mutations can be acquired during metastatic cancer and their development represents a previously unreported mechanism of resistance to treatment.
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Results 1 - 10 of 147
Results 1 - 10 of 147