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Olaparib for BRCA-mutated advanced ovarian cancer

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Olaparib for BRCA-mutated advanced ovarian cancer
Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the fifth most common cause of cancer-related mortality. Treatment options, particularly for tumors with mutations in the breast cancer susceptibility genes, BRCA1 and BRCA2, are currently limited, and significant research has focused on the development of novel therapies. Inhibitors of poly(ADP)ribose polymerase (PARP), which specifically target BRCA-mutant cancer cells by exploiting the defective DNA repair pathways inherent in these tumors, have proven particularly promising, though clinical development has not been without challenges. Development of olaparib was halted in 2011 following disappointing clinical trial results, but the manufacturer resurrected the drug following retrospective analyses in patients with BRCA1/2 mutations. 

 

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The Journal of Community and Supportive Oncology - 13(6)
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Page Number
206-208
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olaparib, Epithelial ovarian cancer, BRCA1, BRCA2, PARP inhibitors, BRCA-mutated,

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Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the fifth most common cause of cancer-related mortality. Treatment options, particularly for tumors with mutations in the breast cancer susceptibility genes, BRCA1 and BRCA2, are currently limited, and significant research has focused on the development of novel therapies. Inhibitors of poly(ADP)ribose polymerase (PARP), which specifically target BRCA-mutant cancer cells by exploiting the defective DNA repair pathways inherent in these tumors, have proven particularly promising, though clinical development has not been without challenges. Development of olaparib was halted in 2011 following disappointing clinical trial results, but the manufacturer resurrected the drug following retrospective analyses in patients with BRCA1/2 mutations. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 
Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the fifth most common cause of cancer-related mortality. Treatment options, particularly for tumors with mutations in the breast cancer susceptibility genes, BRCA1 and BRCA2, are currently limited, and significant research has focused on the development of novel therapies. Inhibitors of poly(ADP)ribose polymerase (PARP), which specifically target BRCA-mutant cancer cells by exploiting the defective DNA repair pathways inherent in these tumors, have proven particularly promising, though clinical development has not been without challenges. Development of olaparib was halted in 2011 following disappointing clinical trial results, but the manufacturer resurrected the drug following retrospective analyses in patients with BRCA1/2 mutations. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 
Issue
The Journal of Community and Supportive Oncology - 13(6)
Issue
The Journal of Community and Supportive Oncology - 13(6)
Page Number
206-208
Page Number
206-208
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Olaparib for BRCA-mutated advanced ovarian cancer
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Olaparib for BRCA-mutated advanced ovarian cancer
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olaparib, Epithelial ovarian cancer, BRCA1, BRCA2, PARP inhibitors, BRCA-mutated,

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olaparib, Epithelial ovarian cancer, BRCA1, BRCA2, PARP inhibitors, BRCA-mutated,

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Blinatumomab for hard-to-treat form of acute lymphoblastic leukemia

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Blinatumomab for hard-to-treat form of acute lymphoblastic leukemia

The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).1 Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.2

 

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The Journal of Community and Supportive Oncology - 13(5)
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Page Number
170-172
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acute lymphoblastic leukemia, ALL, blinatumomab, Philadelphia chromosome-negative precursor, B-cell acute lymphoblastic leukemia, BCP-ALL, CD19, CD3, allo-hematopoietic stem-cell transplantation, allo-HSCT
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The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).1 Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.2

 

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The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).1 Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.2

 

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Issue
The Journal of Community and Supportive Oncology - 13(5)
Issue
The Journal of Community and Supportive Oncology - 13(5)
Page Number
170-172
Page Number
170-172
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Blinatumomab for hard-to-treat form of acute lymphoblastic leukemia
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Blinatumomab for hard-to-treat form of acute lymphoblastic leukemia
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acute lymphoblastic leukemia, ALL, blinatumomab, Philadelphia chromosome-negative precursor, B-cell acute lymphoblastic leukemia, BCP-ALL, CD19, CD3, allo-hematopoietic stem-cell transplantation, allo-HSCT
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acute lymphoblastic leukemia, ALL, blinatumomab, Philadelphia chromosome-negative precursor, B-cell acute lymphoblastic leukemia, BCP-ALL, CD19, CD3, allo-hematopoietic stem-cell transplantation, allo-HSCT
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Palonosetron and netupitant for prevention of chemotherapy-induced nausea and vomiting

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Palonosetron and netupitant for prevention of chemotherapy-induced nausea and vomiting

The US Food and Drug Administration (FDA) recently approved NEPA, an oral fixed-dose combination of netupitant and palonosetron for treatment of chemotherapy-induced nausea and vomiting (CINV). Palonosetron is a pharmacologically distinct, best-in-class serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist, which prevents CINV during the acute phase (0-24 h) after administration of chemotherapy, and netupitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist, which prevents CINV during both the acute and delayed (25-120 h) phases. The 2 agents have also been shown potentially to act synergistically in inhibiting NK-1 receptor activity.

 

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The Journal of Community and Supportive Oncology - 13(4)
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128-130
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Palonosetron, netupitant, chemotherapy-induced nausea and vomiting, CINV
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The US Food and Drug Administration (FDA) recently approved NEPA, an oral fixed-dose combination of netupitant and palonosetron for treatment of chemotherapy-induced nausea and vomiting (CINV). Palonosetron is a pharmacologically distinct, best-in-class serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist, which prevents CINV during the acute phase (0-24 h) after administration of chemotherapy, and netupitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist, which prevents CINV during both the acute and delayed (25-120 h) phases. The 2 agents have also been shown potentially to act synergistically in inhibiting NK-1 receptor activity.

 

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The US Food and Drug Administration (FDA) recently approved NEPA, an oral fixed-dose combination of netupitant and palonosetron for treatment of chemotherapy-induced nausea and vomiting (CINV). Palonosetron is a pharmacologically distinct, best-in-class serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist, which prevents CINV during the acute phase (0-24 h) after administration of chemotherapy, and netupitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist, which prevents CINV during both the acute and delayed (25-120 h) phases. The 2 agents have also been shown potentially to act synergistically in inhibiting NK-1 receptor activity.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 13(4)
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The Journal of Community and Supportive Oncology - 13(4)
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128-130
Page Number
128-130
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Palonosetron and netupitant for prevention of chemotherapy-induced nausea and vomiting
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Palonosetron and netupitant for prevention of chemotherapy-induced nausea and vomiting
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Palonosetron, netupitant, chemotherapy-induced nausea and vomiting, CINV
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Palonosetron, netupitant, chemotherapy-induced nausea and vomiting, CINV
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Palbociclib and letrozole for ER-positive, HER2-negative advanced breast cancer

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Palbociclib and letrozole for ER-positive, HER2-negative advanced breast cancer
On February 3, 2015, the US Food and Drug Administration (FDA) approved palbociclib in combination with letrozole for first-line treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. The combination was reviewed and approved 2 months ahead of schedule under the FDA’s breakthrough therapy designation and priority review program. Palbociclib is an oral small molecule inhibitor of cyclin-dependent kinases (CDK) 4 and 6, while letrozole is an aromatase inhibitor (AI), a type of endocrine therapy that reduces circulating estrogen levels. The 2 agents were shown to have potentially synergistic tumor growth inhibitory activity in preclinical models of ER-positive breast cancer.

 

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The Journal of Community and Supportive Oncology - 13(3)
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83-86
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Palbociclib, letrozole, breast cancer, ER-positive, HER2-negative, f cyclin-dependent kinases, CDK4, CDK6
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On February 3, 2015, the US Food and Drug Administration (FDA) approved palbociclib in combination with letrozole for first-line treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. The combination was reviewed and approved 2 months ahead of schedule under the FDA’s breakthrough therapy designation and priority review program. Palbociclib is an oral small molecule inhibitor of cyclin-dependent kinases (CDK) 4 and 6, while letrozole is an aromatase inhibitor (AI), a type of endocrine therapy that reduces circulating estrogen levels. The 2 agents were shown to have potentially synergistic tumor growth inhibitory activity in preclinical models of ER-positive breast cancer.

 

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On February 3, 2015, the US Food and Drug Administration (FDA) approved palbociclib in combination with letrozole for first-line treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. The combination was reviewed and approved 2 months ahead of schedule under the FDA’s breakthrough therapy designation and priority review program. Palbociclib is an oral small molecule inhibitor of cyclin-dependent kinases (CDK) 4 and 6, while letrozole is an aromatase inhibitor (AI), a type of endocrine therapy that reduces circulating estrogen levels. The 2 agents were shown to have potentially synergistic tumor growth inhibitory activity in preclinical models of ER-positive breast cancer.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 13(3)
Issue
The Journal of Community and Supportive Oncology - 13(3)
Page Number
83-86
Page Number
83-86
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Palbociclib and letrozole for ER-positive, HER2-negative advanced breast cancer
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Palbociclib and letrozole for ER-positive, HER2-negative advanced breast cancer
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Palbociclib, letrozole, breast cancer, ER-positive, HER2-negative, f cyclin-dependent kinases, CDK4, CDK6
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Palbociclib, letrozole, breast cancer, ER-positive, HER2-negative, f cyclin-dependent kinases, CDK4, CDK6
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Ramucirumab for advanced gastric or GEJ adenocarcinoma in previously treated patients with disease progression

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Ramucirumab for advanced gastric or GEJ adenocarcinoma in previously treated patients with disease progression
Ramucirumab was approved by the US Food and Drug Administration for use as a single agent in the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after treatment with fluoropyrimidine- or platinum-containing chemotherapy.1,2 Ramucirumab is a recombinant human IgG1 monoclonal antibody directed at vascular endothelial growth factor receptor 2 (VEGFR2). By binding VEGFR2, ramucirumab blocks binding of the VEGFR ligands VEGF-A, VEGF-C, and VEGF-D and thus inhibits ligand-stimulated activation of VEGFR2, including ligand-induced proliferation and migration of endothelial cells. Ramucirumab was shown to inhibit angiogenesis in vivo in animal models. The approval was based on the finding of improved overall survival (OS) in the international double-blind phase 3 REGARD trial (study I4T-IE-JVBD).2,3 Ramucirumab is the first biological treatment given as a single drug that has produced survival benefit in advanced gastric or GEJ adenocarcinoma progressing after first-line treatment, and the study findings validate VEGFR2 signaling as an important target in advanced gastric cancer. 

 

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The Journal of Community and Supportive Oncology - 12(12)
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Page Number
428-430
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gastric cancer, ramucirumab, anti-VEGF, bevacizumab, aflibercept
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Ramucirumab was approved by the US Food and Drug Administration for use as a single agent in the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after treatment with fluoropyrimidine- or platinum-containing chemotherapy.1,2 Ramucirumab is a recombinant human IgG1 monoclonal antibody directed at vascular endothelial growth factor receptor 2 (VEGFR2). By binding VEGFR2, ramucirumab blocks binding of the VEGFR ligands VEGF-A, VEGF-C, and VEGF-D and thus inhibits ligand-stimulated activation of VEGFR2, including ligand-induced proliferation and migration of endothelial cells. Ramucirumab was shown to inhibit angiogenesis in vivo in animal models. The approval was based on the finding of improved overall survival (OS) in the international double-blind phase 3 REGARD trial (study I4T-IE-JVBD).2,3 Ramucirumab is the first biological treatment given as a single drug that has produced survival benefit in advanced gastric or GEJ adenocarcinoma progressing after first-line treatment, and the study findings validate VEGFR2 signaling as an important target in advanced gastric cancer. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Ramucirumab was approved by the US Food and Drug Administration for use as a single agent in the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after treatment with fluoropyrimidine- or platinum-containing chemotherapy.1,2 Ramucirumab is a recombinant human IgG1 monoclonal antibody directed at vascular endothelial growth factor receptor 2 (VEGFR2). By binding VEGFR2, ramucirumab blocks binding of the VEGFR ligands VEGF-A, VEGF-C, and VEGF-D and thus inhibits ligand-stimulated activation of VEGFR2, including ligand-induced proliferation and migration of endothelial cells. Ramucirumab was shown to inhibit angiogenesis in vivo in animal models. The approval was based on the finding of improved overall survival (OS) in the international double-blind phase 3 REGARD trial (study I4T-IE-JVBD).2,3 Ramucirumab is the first biological treatment given as a single drug that has produced survival benefit in advanced gastric or GEJ adenocarcinoma progressing after first-line treatment, and the study findings validate VEGFR2 signaling as an important target in advanced gastric cancer. 

 

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The Journal of Community and Supportive Oncology - 12(12)
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The Journal of Community and Supportive Oncology - 12(12)
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428-430
Page Number
428-430
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Ramucirumab for advanced gastric or GEJ adenocarcinoma in previously treated patients with disease progression
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Ramucirumab for advanced gastric or GEJ adenocarcinoma in previously treated patients with disease progression
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gastric cancer, ramucirumab, anti-VEGF, bevacizumab, aflibercept
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gastric cancer, ramucirumab, anti-VEGF, bevacizumab, aflibercept
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Mechlorethamine gel for early stage mycosis fungoides-type CTCL

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Mechlorethamine gel for early stage mycosis fungoides-type CTCL
The orphan drug mechlorethamine gel was approved by the US Food and Drug Administration for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received previous skin-directed therapy. It is the first and only approved topical formulation of mechlorethamine. Mechlorethamine, also known as nitrogen mustard, is an alkylating agent that inhibits rapidly proliferating cells. It is applied topically once a day and dries on the skin. 

 

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The Journal of Community and Supportive Oncology - 12(8)
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Page Number
269-270
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mycosis fungoides, Mf, cutaneous T-cell lymphoma, CTCL, mechlorethamine gel
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The orphan drug mechlorethamine gel was approved by the US Food and Drug Administration for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received previous skin-directed therapy. It is the first and only approved topical formulation of mechlorethamine. Mechlorethamine, also known as nitrogen mustard, is an alkylating agent that inhibits rapidly proliferating cells. It is applied topically once a day and dries on the skin. 

 

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The orphan drug mechlorethamine gel was approved by the US Food and Drug Administration for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received previous skin-directed therapy. It is the first and only approved topical formulation of mechlorethamine. Mechlorethamine, also known as nitrogen mustard, is an alkylating agent that inhibits rapidly proliferating cells. It is applied topically once a day and dries on the skin. 

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 12(8)
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The Journal of Community and Supportive Oncology - 12(8)
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269-270
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269-270
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Mechlorethamine gel for early stage mycosis fungoides-type CTCL
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Mechlorethamine gel for early stage mycosis fungoides-type CTCL
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mycosis fungoides, Mf, cutaneous T-cell lymphoma, CTCL, mechlorethamine gel
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mycosis fungoides, Mf, cutaneous T-cell lymphoma, CTCL, mechlorethamine gel
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Trametinib plus dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations

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Trametinib plus dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations

On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.1,2 Approval of the combination is based on durable response rate observed in an open-label study.2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

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The Journal of Community and Supportive Oncology - 12(7)
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234-235
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metastatic melanoma, BRAF, MEK
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On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.1,2 Approval of the combination is based on durable response rate observed in an open-label study.2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

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On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.1,2 Approval of the combination is based on durable response rate observed in an open-label study.2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

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The Journal of Community and Supportive Oncology - 12(7)
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The Journal of Community and Supportive Oncology - 12(7)
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234-235
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234-235
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Trametinib plus dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations
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Trametinib plus dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations
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metastatic melanoma, BRAF, MEK
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metastatic melanoma, BRAF, MEK
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Cobas HPV test for first-line screening for cervical cancer

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Cobas HPV test for first-line screening for cervical cancer

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

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The Journal of Community and Supportive Oncology - 12(5)
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156-157
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On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

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On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

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The Journal of Community and Supportive Oncology - 12(5)
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The Journal of Community and Supportive Oncology - 12(5)
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156-157
Page Number
156-157
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Cobas HPV test for first-line screening for cervical cancer
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Cobas HPV test for first-line screening for cervical cancer
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cervical cancer, cobas HPV test, ATHENA trial, cervical intraepithelia neoplasia, CIN
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cervical cancer, cobas HPV test, ATHENA trial, cervical intraepithelia neoplasia, CIN
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Obinutuzumab for previously untreated chronic lymphocytic leukemia

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Obinutuzumab for previously untreated chronic lymphocytic leukemia
Obinutuzumab was approved by the Food and Drug Administration in late 2013 for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).1,2 The approval was based on results of an open-label phase 3 trial that showed improved progression-free survival (PFS) with the combination of obinutuzumab plus chlorambucil compared with chlorambucil alone. Obinutuzumab is a monoclonal antibody that targets CD20 antigen expressed on the surface of pre B- and mature B-lymphocytes. After binding to CD20, obinutuzumab mediates B-cell lysis by engaging immune effector cells, directly activating intracellular death signaling pathways, and activating the complement cascade. Immune effector cell activities include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

 

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The Journal of Community and Supportive Oncology - 12(4)
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118-120
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obinutuzumab, chronic lymphocytic leukemia, CLL, CD20, CLL11 trial
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Obinutuzumab was approved by the Food and Drug Administration in late 2013 for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).1,2 The approval was based on results of an open-label phase 3 trial that showed improved progression-free survival (PFS) with the combination of obinutuzumab plus chlorambucil compared with chlorambucil alone. Obinutuzumab is a monoclonal antibody that targets CD20 antigen expressed on the surface of pre B- and mature B-lymphocytes. After binding to CD20, obinutuzumab mediates B-cell lysis by engaging immune effector cells, directly activating intracellular death signaling pathways, and activating the complement cascade. Immune effector cell activities include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

 

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Obinutuzumab was approved by the Food and Drug Administration in late 2013 for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).1,2 The approval was based on results of an open-label phase 3 trial that showed improved progression-free survival (PFS) with the combination of obinutuzumab plus chlorambucil compared with chlorambucil alone. Obinutuzumab is a monoclonal antibody that targets CD20 antigen expressed on the surface of pre B- and mature B-lymphocytes. After binding to CD20, obinutuzumab mediates B-cell lysis by engaging immune effector cells, directly activating intracellular death signaling pathways, and activating the complement cascade. Immune effector cell activities include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

 

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 12(4)
Issue
The Journal of Community and Supportive Oncology - 12(4)
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118-120
Page Number
118-120
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Obinutuzumab for previously untreated chronic lymphocytic leukemia
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Obinutuzumab for previously untreated chronic lymphocytic leukemia
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obinutuzumab, chronic lymphocytic leukemia, CLL, CD20, CLL11 trial
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obinutuzumab, chronic lymphocytic leukemia, CLL, CD20, CLL11 trial
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Pertuzumab in neoadjuvant treatment of HER2-positive early breast cancer

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Pertuzumab in neoadjuvant treatment of HER2-positive early breast cancer

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.1 The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

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The Journal of Community and Supportive Oncology - 12(3)
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84-86
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Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.1 The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

Click on the PDF icon at the top of this introduction to read the full article.

 

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.1 The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

Click on the PDF icon at the top of this introduction to read the full article.

 

Issue
The Journal of Community and Supportive Oncology - 12(3)
Issue
The Journal of Community and Supportive Oncology - 12(3)
Page Number
84-86
Page Number
84-86
Publications
Publications
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Display Headline
Pertuzumab in neoadjuvant treatment of HER2-positive early breast cancer
Display Headline
Pertuzumab in neoadjuvant treatment of HER2-positive early breast cancer
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HER2-positive breast cancer, pertuzumab, docetaxel, trastuzumab
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HER2-positive breast cancer, pertuzumab, docetaxel, trastuzumab
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JCSO 2014;12:84-86
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