In May 2023, the U.S. Food and Drug Administration (FDA) announced it had granted accelerated approval for the first CD20 bispecific antibody drug, epcoritamab-bysp (Epkinly^™) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In June 2024, the FDA expanded the indication with accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On August 15, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi^®) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery, for adults with resectable (tumors that are 4 cm or larger or node positive) non-small cell lung cancer and no known epidermal growth factor receptor variants or anaplastic lymphoma kinase rearrangements.

On August 6, 2024, the U.S. Food and Drug Administration (FDA) announced that Smiths Medical is issuing a correction recall for its CADD-Solis Ambulatory Infusion Pump because of multiple issues related to outdated software. The FDA said that the recall involves correcting certain devices, not removing them from where they are used or sold. 

On August 6, 2024, the U.S. Food and Drug Administration approved vorasidenib (Voranigo®), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients aged 12 and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 variant, following surgery including biopsy, subtotal resection, or gross total resection.

In response to the ever-changing practice of cancer care, in May 2024, the American Society of Clinical Oncology (ASCO) and ONS released updates to their administration safety standards to provide clarification and guidance for oncology healthcare professionals. Here’s what you need to know about the changes as an oncology nurse.

In nursing school, we learned that the maximum volume for a single subcutaneous (SC) injection is 1.5–2 ml. However, today’s unique antineoplastic formulations may require volumes up to 15 ml (e.g., daratumumab and hyaluronidase-fihj), forcing nurses to rethink administration practices. Currently, evidence on large-volume SC administration procedures is sparse, making it difficult to determine best practice. 

An integrated screening and stepped collaborative care strategy produced a greater improvement in patients’ quality of life (QOL) and management of depression, pain, and fatigue during the first six months of cancer treatment, researcher reported in study findings published in The Lancet. Patients maintained the benefits at 12 months, as well.

Study participants with clear-cell renal cell carcinoma who received pembrolizumab after surgery had nearly 40% increased overall survival during the first four years after treatment, researchers reported in the New England Journal of Medicine.

On June 26, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp (Epkinly^™), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On February 16, 2024, the U.S. Food and Drug Administration approved the first tumor-infiltrating lymphocyte cancer therapy for metastatic melanoma, lifileucel (Amtagvi™). Patients in the drug’s clinical trial experienced a significant decrease in tumor burden, and the median overall survival was 17.4 months.

On June 21, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati^®) plus cetuximab for adults with KRAS G12C-variant locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

By representing perspectives from the entire cancer care team, collaboration with interprofessional colleagues is one way for oncology nurses to influence the delivery of high-quality patient care.

On June 17, 2024, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

Medicine marked a major milestone in April 2024, the U.S. Food and Drug Administration (FDA) said, when the agency announced it had approved its 50th biosimilar medication. Trastuzumab-strf, a biosimilar to the antineoplastic trastuzumab, had the honor of being the agency's 50th approval.

Merkel cell carcinoma (MCC) is a rare but aggressive form of skin cancer—although it is 40 times rarer than melanoma, it is 3–5 times more lethal. Approximately 3,000 new cases of Merkel cell carcinoma are diagnosed every year in the United States, but its incidence is increasing because of enhanced diagnostic techniques and the prevalence of risk factors.

On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved blinatumomab (Blincyto^®) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapy.

On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi^®) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

On June 12, 2024, the U.S. Food and Drug Administration (FDA) granted traditional approval to selpercatinib (Retevmo^®) for adult and pediatric patients aged 2 years and older with advanced or metastatic RET fusion–positive thyroid cancer that requires systemic therapy but is refractory to radioactive iodine (RAI), if RAI is appropriate.

On June 6, 2024, the U.S. Food and Drug Administration (FDA) approved imetelstat (Rytelo^™), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks that has not responded to, has lost response to, or is ineligible for erythropoiesis-stimulating agents.

On May 30, 2024, the U.S. Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi^®) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

On May 29, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo^®) for pediatric patients aged 2 and older. This is the first FDA approval of a targeted therapy for pediatric patients younger than 12 with RET alterations.

Eflornithine (Iwilfin™) is the first U.S. Food and Drug Administration–approved oral maintenance therapy for high-risk neuroblastoma. Approved in December 2023, eflornithine has an orphan drug designation.

On May 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tarlatamab-dlle (Imdelltra™) for extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

On May 15, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (Breyanzi^®) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

On April 23, 2024, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate (Lutathera^®) for pediatric patients aged 12 and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors. FDA approved lutetium Lu 177 dotatate for the indication for adults in 2018.

On April 23, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tovorafenib (Ojemda™) for patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement or BRAF V600 variant.

On April 22, 2024, the U.S. Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva^®) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

The first innovation in stem cell mobilization for multiple myeloma in a decade, motixafortide (Aphexda™) received U.S. Food and Drug Administration approval on September 11, 2023. The drug’s clinical trial demonstrated that one dose of motixafortide plus filgrastim enabled a majority of patients to achieve the collection goal of at least six million hematopoietic stem cells.

A record-breaking 323 drugs are currently in shortage in the United States, according to April 2024 ASHP data. In tandem timing, the U.S. Department of Health and Human Services (HHS) announced its plan to prevent and mitigate drug shortages and proposed new solutions for policymakers to consider in an April 2024 white paper.

On April 18, 2024, the U.S. Food and Drug Administration (FDA) approved alectinib (Alecensa^®) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)–positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

On April 5, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu^®) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. It is one of seven anticancer agents with a tumor-agnostic FDA approval.

Since 1995, the U.S. Food and Drug Administration (FDA) has received submissions for more than 300 drugs and biological products with artificial intelligence (AI) components and more than 700 AI-enabled devices, Commissioner Robert M. Califf, MD, said in a March 2024 blog post.  

On March 22, 2024, the U.S. Food and Drug Administration (FDA) fully approved mirvetuximab soravtansine-gynx (Elahere^®) for adult patients with FR alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Patients are selected for treatment based on an FDA-approved test. FDA gave mirvetuximab soravtansine-gynx accelerated approval for the indication in November 2022.

On March 21, 2024, the U.S. Food and Drug Administration (FDA) approved safety labeling changes regarding dihydropyrimidine dehydrogenase deficiency for fluorouracil injection products. The update was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence.

Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) today announced their commitment to working on bipartisan healthcare legislation to prevent and mitigate shortages of critical generic drugs used by patients and providers in the United States. In a white paper released today, Wyden and Crapo outlined concerns raised by experts at a hearing held in the Finance Committee on December 5, 2023, as well as areas of interest and ideas the Committee is exploring to address the factors contributing to shortages through modifications to the Medicare and Medicaid programs.

On March 19, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ponatinib (Iclusig^®) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

Since the first bispecific antibody (BsAb), blinatumomab, received U.S. Food and Drug Administration approval in 2014, the drug class has developed exponentially, with the majority of currently approved agents entering clinical practice in the past two years. BsAbs are very effective for treating certain malignancies, including multiple myeloma and leukemia, and most are approved for oncology indications. Here’s what makes BsAbs different than other cancer treatments and the key considerations for oncology nursing clinical practice.

The U.S. House Committee on Oversight and Accountability in late February 2024 called pharmaceutical companies to provide more information and a briefing to explain the ongoing shortages of several cancer drugs, including carboplatin, cisplatin, and methotrexate; amoxicillin; and stimulant medications.

On March 7, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa^®) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

On March 6, 2024, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa^®) for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

On March 1, 2024, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant^®) with carboplatin and pemetrexed for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion variants, as detected by an FDA-approved test.

Some young adult patients who receive fertility-sparing surgery for early-stage cervical cancer may be able to extend their follow-up intervals to 6 or even 12 months, researchers reported in study results published in Lancet Oncology.

On February 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi™), a tumor-derived autologous T-cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1–blocking antibody and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso^®) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R variants, as detected by an FDA-approved test.

On February 15, 2024, the U.S. Food and Drug Administration (FDA) granted traditional approval to tepotinib (Tepmetko^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.

On February 13, 2024, the U.S. Food and Drug Administration approved irinotecan liposome (Onivyde^®) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.

Nivolumab with chemotherapy and pembrolizumab with enfortumab vedotin-ejfv, an antibody-drug conjugate, are superior to standard chemotherapy as initial treatment for patients with advanced bladder cancer, researchers reported in study results from the Checkmate-901 and EV-302 clinical trials. The studies represent major strides in treatment for advanced bladder cancer, which has not seen changes in standard initial therapy for many years.

On January 19, 2024, the U.S. Food and Drug Administration (FDA) approved erdafitinib (Balversa^®) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. The approval amends erdafitinib’s previous accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.

On January 12, 2024, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) with chemoradiotherapy for patients with FIGO 2014 stage III–IVA cervical cancer.

Margetuximab-cmkb (Margenza^®) received U.S. Food and Drug Administration approval in December 2020 for previously treated adults with metastatic HER2-positive breast cancer after clinical trials demonstrated increased progression-free and overall survival.