User login
Trabectedin expands treatment options for some forms of advanced soft tissue sarcoma
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
More success for immunotherapy with nivolumab approval for metastatic RCC
Encapsulated irinotecan provides novel option for hard-to-treat pancreatic cancer
In the fall of 2015, the US Food and Drug Administration approved the addition of a novel, much-needed treatment option for patients with metastatic pancreatic cancer, a particularly hard-to-treat form of the disease, in the second-line setting following progression on gemcitabine- based chemotherapy.1 MM-398 is a modified version of the chemotherapeutic agent irinotecan, in which the drug is encapsulated in a nanoliposomal construct that is designed to improve delivery to the tumor and enhance anti-tumor efficacy while minimizing side effects in the rest of the body.
Click on the PDF icon at the top of this introduction to read the full article.
In the fall of 2015, the US Food and Drug Administration approved the addition of a novel, much-needed treatment option for patients with metastatic pancreatic cancer, a particularly hard-to-treat form of the disease, in the second-line setting following progression on gemcitabine- based chemotherapy.1 MM-398 is a modified version of the chemotherapeutic agent irinotecan, in which the drug is encapsulated in a nanoliposomal construct that is designed to improve delivery to the tumor and enhance anti-tumor efficacy while minimizing side effects in the rest of the body.
Click on the PDF icon at the top of this introduction to read the full article.
In the fall of 2015, the US Food and Drug Administration approved the addition of a novel, much-needed treatment option for patients with metastatic pancreatic cancer, a particularly hard-to-treat form of the disease, in the second-line setting following progression on gemcitabine- based chemotherapy.1 MM-398 is a modified version of the chemotherapeutic agent irinotecan, in which the drug is encapsulated in a nanoliposomal construct that is designed to improve delivery to the tumor and enhance anti-tumor efficacy while minimizing side effects in the rest of the body.
Click on the PDF icon at the top of this introduction to read the full article.
Second targeted combination regime approved for metastatic melanoma
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Idarucizumab given the nod as the first specific antidote for an oral anticoagulant
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Filgrastim-sndz debuts as the first biosimilar approved in United States
Approval reinstates gefitinib as a therapy for lung cancer
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Dinutuximab combination therapy becomes first approval for high-risk neuroblastoma
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
Nivolumab: first immunotherapy approved for lung cancer
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Panobinostat: a novel mechanism of action shows promise in multiple myeloma
Following an initial “no” vote from the Oncologic Drugs Advisory Committee (ODAC) in late 2014, the US Food and Drug Administration eventually awarded accelerated approval in February 2015 to the histone deacetylase (HDAC) inhibitor panobinostat for use in select patients with relapsed multiple myeloma. Panobinostat has a novel mechanism of action that demonstrates synergy with the proteasome inhibitor bortezomib and the immunomodulatory agent dexamethasone, which translated into improved progression-free survival (PFS) for patients with multiple myeloma who had received at least 2 prior therapies, according to data from a prespecified subgroup analysis from the Panorama-1 trial.
Click on the PDF icon at the top of this introduction to read the full article.
Following an initial “no” vote from the Oncologic Drugs Advisory Committee (ODAC) in late 2014, the US Food and Drug Administration eventually awarded accelerated approval in February 2015 to the histone deacetylase (HDAC) inhibitor panobinostat for use in select patients with relapsed multiple myeloma. Panobinostat has a novel mechanism of action that demonstrates synergy with the proteasome inhibitor bortezomib and the immunomodulatory agent dexamethasone, which translated into improved progression-free survival (PFS) for patients with multiple myeloma who had received at least 2 prior therapies, according to data from a prespecified subgroup analysis from the Panorama-1 trial.
Click on the PDF icon at the top of this introduction to read the full article.
Following an initial “no” vote from the Oncologic Drugs Advisory Committee (ODAC) in late 2014, the US Food and Drug Administration eventually awarded accelerated approval in February 2015 to the histone deacetylase (HDAC) inhibitor panobinostat for use in select patients with relapsed multiple myeloma. Panobinostat has a novel mechanism of action that demonstrates synergy with the proteasome inhibitor bortezomib and the immunomodulatory agent dexamethasone, which translated into improved progression-free survival (PFS) for patients with multiple myeloma who had received at least 2 prior therapies, according to data from a prespecified subgroup analysis from the Panorama-1 trial.
Click on the PDF icon at the top of this introduction to read the full article.