FDA Approves Encorafenib in Combination With Cetuximab for Metastatic Colorectal Cancer With a BRAF V600E Mutation
On April 8, 2020, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi®) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy.
FDA Approves Luspatercept-Aamt for Anemia in Adults With MDS
On April 3, 2020, the U.S. Food and Drug Administration (FDA) approved luspatercept-aamt (Reblozyl®) for the treatment of anemia failing an erythropoiesis-stimulating agent and requiring two or more red blood cell (RBC) units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer
On March 27, 2020, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi®) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Oncology Drug Reference Sheet: Daratumumab
Daratumumab (Darzalex®) was originally approved by the U.S. Food and Drug Administration in 2015 with additional indications added since. The most recent new indication was approved in September 2019 for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplantation.
Pembrolizumab Is More Cost Effective Than Atezolizumab for NSCLC
Adding atezolizumab to treatment with bevacizumab, carboplatin, and paclitaxel as first-line therapy for metastatic, nonsquamous non-small cell lung cancer (NSCLC) is associated with survival benefit—but it comes at a cost, researchers said in study results published in JAMA Network Open. In comparison, pembrolizumab offers a more cost-effective survival benefit.
Oncology Drug Reference Sheet: Panitumumab (Vectibix®)
Approved in 2006 as monotherapy for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) after disease progression following treatment, panitumumab has been a mainstay metastatic disease for more than a decade. In 2014, it received additional indication as first-line therapy for the treatment of patients with EGFR-expressing mCRC in combination with FOLFOX, but in 2017, use was narrowed to wild-type RAS (not mutated RAS).
FDA Grants Accelerated Approval to Nivolumab and Ipilimumab Combination for Hepatocellular Carcinoma
On March 10, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab and ipilimumab (Opdivo® and Yervoy®) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
What the Research Says About Drug Interactions and Medical Cannabis
Despite medical cannabis’s legalization for medical use throughout 31 different jurisdictions in the United States, practicing providers have little research and few guidelines for patient care. To address the gap, in 2018 the National Council of State Boards of Nursing published Nursing Guidelines for Medical Marijuana, which provides general nursing education and guidance—yet doesn’t discuss drug interactions, specifically. To understand how medical cannabis affects concomitant pharmaceuticals, nurses must have a basic knowledge of the endocannabinoid system (ECS).
Biosimilars and Gene Therapy Are Making Great Strides in Cancer Care
As researchers learn more about how combination therapy combats drug resistance and lessens the changes of tumor evasion of the immune system, immune checkpoint inhibitors are receiving approval for a broader range of indications. However, recent U.S. Food and Drug Administration (FDA) approvals have centered around hematologic malignancies and the emergence of two new biosimilars.
FDA Approves Epoetin Alfa-Epbx as a Biosimilar to Epoetin Alfa
On May 15, 2018, the U.S. Food and Drug Administration approved epoetin alfa-epbx (Retacrit™) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia due to chronic kidney disease.
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.
Statin Use May Improve Overall Survival From Multiple Myeloma
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.