FDA Approves First Biosimilar for Cancer Treatment
On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Senate Passes Bill to Focus on Childhood Cancer Treatments
A new bill passed in the U.S. Senate last week will provide measures to ensure that drug companies are developing treatments for children with cancer. The RACE for Children Act is part of the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017, which aims to speed up the approval process for new treatments and medical devices and is expected to be signed into law by President Trump.
FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Patients With AML
On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos™, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.
Safely Provide Outpatient Care to Patients Receiving Hematopoietic Stem Cell Transplantations
High-dose chemotherapy with hematopoietic stem cell support is a well-established treatment for many hematologic malignancies. This treatment can be a difficult journey for patients and families. Historically, patients have been treated in a traditional hospital setting in anticipation of severe side effects, including mucositis, febrile neutropenia, thrombocytopenia, and pulmonary, renal, and hepatic complications. Patients can remain profoundly immunosuppressed for months while recovering from transplant. However, better supportive care in recent years has allowed many centers to move all or a portion of their transplant care into an outpatient setting.
How the Evolution of Immunotherapy Will Impact Oncology Nurses
Immunotherapy is one of the fastest-evolving areas of oncology to date. Previously, it could take years for some cancers to see new treatment options; today, the U.S. Food and Drug Administration is approving new immuno-oncology agents or new indications for those agents every few weeks. It’s a boon and a challenge to medical professionals. On the one hand, potentially life-changing treatments are making way to patients who need them—patients who have exhausted first-line treatments and now have limited options. On the other hand, healthcare professionals may struggle to stay current with the emerging trends, cutting-edge science, and evolving treatment plans for their patients.
FDA Approves Midostaurin for FLT3-Positive Adult AML, Advanced Systemic Mastocytosis
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
FDA Issues Warnings to Fraudulent Cancer Treatment Companies
On April 25, 2017, the U.S. Food and Drug Administration (FDA) issued warning letters to 14 companies that were selling fraudulently marketed products claiming to prevent, diagnose, treat, or cure cancer. In total, the companies produced more than 65 products that have been sold in the United States without FDA approval.
FDA Approves Nivolumab for Advanced or Metastatic Bladder Cancer
On February 2, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
Combination Therapy Shows Promise for Chronic Myeloid Leukemia
According to the results of a new study published in Science Translational Medicine, a combination regimen consisting of a BCR-ABL tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor may one day result in a cure for chronic myeloid leukemia.
FDA Approves Nivolumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
FDA Approves Pembrolizumab for Treatment of Non-Small Cell Lung Cancer
Sentinel Node Dissection Sufficient for Localized Breast Cancer
FDA Approves Olaratumab for Soft Tissue Sarcoma
FDA Approves Atezolizumab for Advanced Non-Small Cell Lung Cancer
FDA Modifies Use of Erlotinib in NSCLC, Used Only in Patients With EGFR Tumor Mutations
Is Scalp Cooling the Right Decision for Your Patients?
Inotuzumab Ozogamicin May Improve Survival in ALL
Does the Sequence of Chemotherapy and Biotherapy Agents Matter?
Poliovirus May Be Key to Treating Glioblastoma
Pembrolizumab Associated With Long-Term Survival in Advanced Melanoma
FDA Approves Pembrolizumab for Head and Neck Squamous Cell Carcinoma
Radiotherapy Optimizes Outcomes and Quality of Life Through Interdisciplinary Care
FDA Offers Expanded Access to Patients in Need of Treatment
FDA Allows Marketing for First Nucleic Acid-Based Quantitation Test for Use During Treatment CML
CDC Advises Against Using Oral Liquid Docusate
Promote Cancer Prevention in the Face of Cancer Treatment
Checkpoint Inhibitors May Cause Pseudoprogression and Dose-Limiting Side Effects
Radiation Plus Chemotherapy Improves Survival From Low-Grade Gliomas
Proteins Targeting Tumor Microenviroment May Block Metastatic Ovarian Cancer Growth
FDA Approves Atezolizumab in Advanced or Metastatic Urothelial Carcinoma
Low-Dose Metformin May Reduce Risk of Colorectal Adenomas
New Treatment Approach May Be Effective for Aggressive Ovarian Cancer
FDA Approves Venetoclax for CLL
FDA Approves Defibrotide Sodium for Hepatic Veno-Occlusive Disease
FDA Approves Crizotinib for ROS1-Positive Lung Cancer
FDA Approves New Indication for Everolimus
FDA Approves New Indication for Obinutuzumab
On February 26, 2016, the U. S. Food and Drug Administration approved obinutuzumab (Gazyva® Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.