FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma
On October 31, 2017, the Food and Drug Administration (FDA) granted accelerated approval to acalabrutinib (Calquence™, AstraZeneca Pharmaceuticals, Inc.) for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
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 Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
On July 17, 2017, the U.S. Food and Drug Administration approved neratinib (Nerlynx™, Puma Biotechnology, Inc.) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Oncology Treatments and Trends Continue to Change Rapidly
“This has been a historic year in oncology pharmacology,” Rowena Schwartz, PharmD, BCOP, associate professor at the University of Cincinnati, told the audience during a session at the 42nd Annual Congress in Denver, CO. “There were new drugs, yes, but we’re really learning how to use the drugs that we have.”
FDA Announces Oncology Center of Excellence
The U.S. Food and Drug Administration (FDA) recently announced, through the Office of Health and Constituent Affairs, that it has established the Oncology Center of Excellence (OCE). Longtime FDA official, Richard Pazdur, MD, has been named to lead the division as its first director. The OCE will make oncology “the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers,” according to the FDA.
Statin Use May Improve Overall Survival From Multiple Myeloma
A new study has found that use of statin medications in patients with multiple myeloma was associated with a decreased risk of all-cause and cancer-specific mortality. The findings were published in the Journal of Clinical Oncology.
Palbociclib Plus Letrozole Improves Survival in Advanced Breast Cancer
An Oncology Nursing Overview of New Immune Checkpoint Inhibitors
MABp1 May Be Effective for Metastatic Colorectal Cancer
Maintenance Treatment May Prolong Progression-Free Survival in Ovarian Cancer
Pembrolizumab Associated With Long-Term Survival in Advanced Melanoma
New Class of Drugs Shows Promise in Treatment-Resistant Prostate Cancer
What Nurses Need to Know About Talimogene Laherparepvec for Advanced Melanoma
Blinatumomab May Induce Remission in Patients With Relapsed or Refractory ALL
Low-Dose Metformin May Reduce Risk of Colorectal Adenomas
Discarded Excess U.S. Cancer Drugs Cost $1.8 Billion per Year
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.