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. 

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).  

On April 1, 2020, the U.S. Food and Drug Administration asked manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

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). 

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. 

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. 

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). 

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. 

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).  

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. 

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.

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.

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.

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.

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.

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.

An interview with Beth Faiman, PhD, CNP, and Kimberly Noonan, NP