The US FDA has withdrawn approval of the breast cancer indication for bevacizumab [Avastin],

2011 ◽  
Vol &NA; (1379) ◽  
pp. 2
Author(s):  
&NA;
Keyword(s):  
Breast Cancer ◽  
The Us ◽  
Us Fda

scholarly journals Potential Utility of Pre-Emptive Germline Pharmacogenetics in Breast Cancer

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1219
Author(s):  
Philip S. Bernard ◽  
Whitney Wooderchak-Donahue ◽  
Mei Wei ◽  
Steven M. Bray ◽  
Kevin C. Wood ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Adverse Events ◽  
Proton Pump ◽  
Gene Interactions ◽  
Potential Utility ◽  
Dose Selection ◽  
The Us ◽  
Inflammatory Drugs ◽  
Us Fda

Patients with breast cancer often receive many drugs to manage the cancer, side effects associated with cancer treatment, and co-morbidities (i.e., polypharmacy). Drug–drug and drug–gene interactions contribute to the risk of adverse events (AEs), which could lead to non-adherence and reduced efficacy. Here we investigated several well-characterized inherited (germline) pharmacogenetic (PGx) targets in 225 patients with breast cancer. All relevant clinical, pharmaceutical, and PGx diplotype data were aggregated into a single unifying informatics platform to enable an exploratory analysis of the cohort and to evaluate pharmacy ordering patterns. Of the drugs recorded, there were 38 for which high levels of evidence for clinical actionability with PGx was available from the US FDA and/or the Clinical Pharmacogenetics Implementation Consortium (CPIC). These data were associated with 10 pharmacogenes: DPYD, CYP2C9, CYP2C19, CYP2D6, CYP3A5, CYP4F2, G6PD, MT-RNR1, SLCO1B1, and VKORC1. All patients were taking at least one of the 38 drugs and had inherited at least one actionable PGx variant that would have informed prescribing decisions if this information had been available pre-emptively. The non-cancer drugs with PGx implications that were common (prescribed to at least one-third of patients) included anti-depressants, anti-infectives, non-steroidal anti-inflammatory drugs, opioids, and proton pump inhibitors. Based on these results, we conclude that pre-emptive PGx testing may benefit patients with breast cancer by informing drug and dose selection to maximize efficacy and minimize AEs.

Breast cancer drug approvals by the US FDA from 1949 to 2018

2019 ◽  
Vol 19 (1) ◽  
pp. 11-11 ◽  
Author(s):  
Chandra P. Leo ◽  
Cornelia Leo ◽  
Thomas D. Szucs
Keyword(s):  
Breast Cancer ◽  
Cancer Drug ◽  
The Us ◽  
Drug Approvals ◽  
Us Fda

scholarly journals Publisher Correction: Breast cancer drug approvals by the US FDA from 1949 to 2018

2020 ◽  
Vol 19 (4) ◽  
pp. 291-291
Author(s):  
Chandra P. Leo ◽  
Cornelia Leo ◽  
Thomas D. Szucs
Keyword(s):  
Breast Cancer ◽  
Cancer Drug ◽  
The Us ◽  
Drug Approvals ◽  
Us Fda

scholarly journals Managing Aromatase Inhibitor-Associated Bone Loss in Breast Cancer

2007 ◽  
Vol 3 (4) ◽  
pp. 441-448 ◽  
Author(s):  
Allan Lipton ◽  
Michael Gnant ◽  
Matti Aapro
Keyword(s):  
Breast Cancer ◽  
Bone Loss ◽  
Aromatase Inhibitor ◽  
Early Stage ◽  
Term Treatment ◽  
Bone Lesions ◽  
Long Term Treatment ◽  
The Us ◽  
Us Fda

Although the incidence of breast cancer has increased, there is a concurrent decrease in the death rate, and the outlook for women with early-stage breast cancer remains positive. The current 5-year survival rate of women diagnosed with breast cancer is nearly 90%, due, in part, to the use of effective adjuvant therapies that often include aromatase inhibitors. However, long-term treatment with these therapies is known to have adverse effects on bone metabolism, leading to bone loss. Bone loss during adjuvant endocrine therapy may be higher than that observed during menopause and may require more potent therapy. Although there are approved treatments for osteolytic bone lesions from bone metastases, there is no approved therapy for bone loss associated with adjuvant cancer therapy. Bisphosphonates have demonstrated promising results in this setting, and zoledronic acid is currently under consideration by the US FDA and Europe (EMEA) for the treatment of aromatase inhibitor-associated bone loss.

Remarkable response to combined immunochemotherapy in patients with metastatic triple-negative breast cancer

Immunotherapy ◽  
2020 ◽  
Vol 12 (18) ◽  
pp. 1293-1302
Author(s):  
Alexander Philipovskiy ◽  
Karinn Chambers ◽  
Ioannis Konstantinidis ◽  
Richard McCallum ◽  
Javier Corral ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Prognostic Role ◽  
Multiple Malignancies ◽  
The Us ◽  
Heavily Pretreated ◽  
Us Fda ◽  
Positive Results

Background: Progress in immunotherapy (IT) has shifted treatment paradigms for multiple malignancies. In March 2019, the combination of nab-paclitaxel and atezolizumab was approved by the US FDA for patients with PD-L1 positive metastatic triple-negative breast cancer based on positive results of the Impassion130 trial. Although numerous studies have examined the prognostic role of PD-L1, the value of this test remains controversial. Results: Here, we presented the cases of three heavily pretreated women with metastatic triple-negative breast cancer who exhibited remarkable responses to combined IT and chemotherapy despite undetectable PD-L1. Conclusion: In our opinion, the current FDA-approved assessment for PD-L1 expression is a reasonable tool for deciding whether to start IT. However, because this approach has many limitations, patients with undetectable PD-L1 expression should still be considered for IT.

Regulatory decisions from the US FDA

2001 ◽  
Vol &NA; (1272) ◽  
pp. 22
Author(s):  
&NA;
Keyword(s):  
The Us ◽  
Us Fda ◽  
Regulatory Decisions

scholarly journals Ravulizumab: a novel C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria

2019 ◽  
Vol 10 ◽  
pp. 204062071987472 ◽  
Author(s):  
Robert M. Stern ◽  
Nathan T. Connell
Keyword(s):  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Bone Marrow Failure ◽  
Phase Iii ◽  
The European Union ◽  
Regulatory Review ◽  
Dosing Schedule ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Us Fda

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare stem cell disorder characterized by hemolytic anemia, bone marrow failure, and thrombosis. Until recently, the complement inhibitor, eculizumab, was the only United States Food and Drug Administration (US FDA)-approved therapy for the treatment of PNH. Although effective, eculizumab requires a frequent dosing schedule that can be burdensome for some patients and increases the risk of breakthrough intravascular hemolysis. Ravulizumab, an eculizumab-like monoclonal antibody engineered to have a longer half-life, is intended to provide the same benefits as eculizumab but with a more convenient and effective dosing schedule. In two recently published phase III non-inferiority trials, ravulizumab was found to be non-inferior to eculizumab both in efficacy and safety for the treatment of patients with PNH. Based on these results, ravulizumab was approved by the US FDA on 21 December 2018 and is currently under regulatory review in both the European Union and Japan.

scholarly journals Mozobil® (Plerixafor, AMD3100), 10 years after its approval by the US Food and Drug Administration

2019 ◽  
Vol 27 ◽  
pp. 204020661982938 ◽  
Author(s):  
Erik De Clercq
Keyword(s):  
Autologous Transplantation ◽  
Hepatopulmonary Syndrome ◽  
Blood Stream ◽  
Malignant Diseases ◽  
Whim Syndrome ◽  
Natural Ligand ◽  
Cxcr4 Receptor ◽  
The Us ◽  
Us Fda ◽  
Anti Hiv

AMD3100 (plerixafor, Mozobil®) was first identified as an anti-HIV agent specifically active against the T4-lymphotropic HIV strains, as it selectively blocked the CXCR4 receptor. Through interference with the interaction of CXCR4 with its natural ligand, SDF-1 (also named CXCL12), it also mobilized the CD34+stem cells from the bone marrow into the peripheral blood stream. In December 2008, AMD3100 was formally approved by the US FDA for autologous transplantation in patients with Non-Hodgkin’s Lymphoma or multiple myeloma. It may be beneficially used in various other malignant diseases as well as hereditary immunological disorders such as WHIM syndrome, and physiopathological processes such as hepatopulmonary syndrome.

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