Chronic graft-versus-host disease (GVHD) is a severe adverse reaction after allogeneic hematopoietic cell transplantation that decreases quality of life and is a major cause of death. In July 2021, the U.S. Food and Drug Administration approved belumosudil (Rezurock^TM) as a third-line treatment option for chronic GVHD.

On May 4, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu^®) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2–based regimen in the metastatic setting as well as those in the neoadjuvant or adjuvant setting who developed disease recurrence during or within six months of completing therapy.

First approved by the U.S. Food and Drug Administration in 2020 for treatment of gastrointestinal stromal tumors (GIST), avapritinib’s (AyvakitTM) approval was extended in 2021 for treatment of advanced systemic mastocytosis (AdvSM). Both approvals are for patients with PDGFR-alpha genetic variants.

On April 5, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to alpelisib (Vijoice^®) for adult and pediatric patients aged two and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.

On April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta^®) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma.

On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium lu 177 vipivotide tetraxetan (Pluvicto™) for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR)–pathway inhibition and taxane-based chemotherapy. 

On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) as a single agent for patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial carcinoma, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.

An optical imaging agent shown to improve diagnostic accuracy, pafolacianine (Cytalux^TM) was approved on November 29, 2021, for use in adult patients with known or suspected ovarian cancer as adjunct therapy in conjunction with planned intraoperative identification of malignant lesions. Pafolacianine is used in combination with a near-infrared (NIR) fluorescence imaging system that requires specialized training provided by the device manufacturer.

On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag™) for adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma. Nivolumab and relatlimab-rmbw is a fixed-dose combination of the LAG-3–blocking antibody relatlimab and the programmed death receptor-1–blocking antibody nivolumab.

On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza^®) for adult patients with deleterious or suspected deleterious germline BRCA variant (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients are selected for therapy based on an FDA-approved companion diagnostic for olaparib.

On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti™) for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.

On March 4, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting, representing the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

On March 3, 2022, the U.S. Food and Drug Administration (FDA) reported B. Braun Medical’s voluntary recall of five lots of 0.9% sodium chloride for injection USP 250 ml in Excel within the United States at the hospital and user levels after receiving reports of fluid leakage or low fill volumes.

In clinical trials, 24% of patients achieved an objective response rate with tisotumab vedotin-tftv (Tivdak^TM) that lasted a median of 8.3 months, leading to the agent’s U.S. Food and Drug Administration September 2021 approval for use in adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Clinicians often use combination cancer therapies to overcome treatment resistance, and one of the newest options for certain patients with multiple myeloma is isatuximab, a monoclonal antibody (mAb). Approved for use in combination with pomalidomide plus dexamethasone to treat adults with relapsed or refractory multiple myeloma who have received at least two prior therapies, isatuximab prolonged progression-free survival by nearly six months and produced an overall response rate of more than 60% in the drug’s clinical trials.

Adding to its earlier approvals for use in adults with acute myeloid leukemia (AML), on August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo^®) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma. Cholangiocarcinoma, or cancer of the bile ducts, is a rare cancer, and ivosidenib is the only currently approved agent for patients with an IDH1 variant.

After clinical trials demonstrated a 40% overall response rate with 63% of responses lasting six months or more, on May 21, 2021, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (Rybrevant^TM) for adult patients with 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, whose disease has progressed on or after platinum-based chemotherapy.

On December 15, 2021, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia^®) for prophylaxis of acute graft-versus-host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients aged 2 and older who are undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele-mismatched unrelated donor.

Many of today’s new drug approvals and standard-of-care treatments have a companion diagnostic test that identifies biomarkers in a patient’s tumor tissue or blood to determine whether they are an appropriate candidate for the therapy. When those results show that they’re not a good match for the U.S. Food and Drug Administration (FDA)-approved treatment, the findings may identify a biomarker-directed clinical trial as an alternative option. Here’s how oncology nurses can help patients understand which clinical trials listed on their test results might be an option for them.

The U.S. Food and Drug Administration’s (FDA’s) expanded access program is a pathway for providers to request using an investigational medical product to treat a patient with an immediately life-threatening or serious disease or condition outside of clinical trials when no comparable or satisfactory alternative therapy options are available. FDA’s Project Facilitate, a comprehensive program within FDA’s Oncology Center of Excellence, makes the pathway more accessible by assisting oncology healthcare professionals in submitting single-patient oncology expanded access applications.

On December 2, 2021, the U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan^®) in combination with chemotherapy for pediatric patients aged at least 6 months to 18 years with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. 

On November 30, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™), carfilzomib (Kyprolis^®), and dexamethasone for adult patients with relapsed or refractory multiple myeloma who received one to three prior lines of therapy.

On November 22, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (Fyarro™) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

After clinical trials demonstrated an overall response rate of 36% and median response duration of 10 months, the U.S. Food and Drug Administration granted sotorasib (Lumakras^TM) accelerated approval on May 28, 2021, for the treatment of adults with KRAS G12C–altered locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix^®) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who were previously treated with two or more tyrosine kinase inhibitors (TKIs). FDA also approved asciminib for adult patients with Ph+ CML in CP with the T315I variation.

A first-of-its-kind antibody-drug conjugate for multiple myeloma, belantamab mafodotin-blmf (Blenrep) received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2020. The approval was based on clinical trial findings that demonstrated a 31% overall response rate that lasted at least six months in 73% of responders.

On October 15, 2021, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq^®) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II–IIIA non-small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 1% of tumor cells as determined by an FDA-approved test. 

On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥ 1), as determined by an FDA-approved test. 

On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio^®) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk for recurrence and a Ki-67 score ≥ 20%, as determined by an FDA-approved test. This is the first CDK4/6 inhibitor approved for adjuvant treatment of breast cancer.  

Initially studied for its radioprotective effects on healthy cells, avasopasem may also increase cancer cells’ response to radiation treatment, researchers reported in Science Translational Medicine.

On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus™) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Initially marketed in April 2020 for treatment of adults with metastatic triple negative breast cancer, sacituzumab govitecan-hziy (Trodelvy^®) received an additional approval in 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer with prior treatments.

On September 22, 2021, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi^®) for chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.

On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx^®) for adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor (VEGFR)-targeted therapy and who are ineligible for or refractory to radioactive iodine treatment.

On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak™), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy.

On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mobocertinib (Exkivity™) for adult patients with 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, whose disease has progressed on or after platinum-based chemotherapy.

On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa^®) for adult patients with Waldenström macroglobulinemia (WM).

On August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo^®) for adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. FDA also approved the Oncomine Dx Target Test as a companion diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib.

On March 10, 2021, the U.S. Food and Drug Administration approved tivozanib (Fotivda^®), an oral kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk for recurrence after undergoing radical resection.

On August 16, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of an additional four lots of varenicline 0.5mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. To date, Pfizer has not received any reports of adverse events that have been related to the recall. FDA reported Pfizer’s recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021.

On August 17, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima®) and pembrolizumab (Keytruda®) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg®), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), that do not require immediate surgery.

On July 28, 2021, the U.S. Food and Drug Administration (FDA) reported that a clinical trial (OCEAN, Study OP-103) evaluating melphalan flufenamide (Pepaxto®) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. 

On July 26, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and continued as a single agent as adjuvant treatment after surgery. 

Pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection (Phesgo^TM) was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for patients with advanced HER2-positive breast cancer. The drug components are the same as those in FDA-approved IV version, and study results showed comparable safety and efficacy to the IV counterparts. The new administration route allows eligible patients to bypass infusion centers or even receive the therapy at home.

On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) in combination with lenvatinib (Lenvima^®) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting, and are not candidates for curative surgery or radiation. 

Prescription overdoses and addiction rates have dramatically increased in the United States since 2012, with more than 70,000 deaths attributed to the abuse of fentanyl, opioids, cocaine, and methamphetamine in 2019, a 35% increase since 2015. Addressing drug misuse is a top priority for the Biden-Harris administration, as well as researching systematic inequities in the country’s approach to criminal justice and prevention, treatment, and recovery.