On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan (Trodelvy^®) for patients with locally advanced or metastatic urothelial cancer  who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.

On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy^®) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who received two or more prior systemic therapies, at least one of which for metastatic disease.

On April 6, 2021, the U.S. Food and Drug Administration (FDA) approved a new dosage regimen for cetuximab (Erbitux^®) of 500 mg/m2 via IV infusion for 120 minutes every two weeks for patients with KRAS wild-type, epidermal growth factor receptor-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

On March 31, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication informing patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems.

On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa^®) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. 

On March 27, 2021, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma), for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma. 

On March 22, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda^®) for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) (tumors with an epicenter 1–5 cm above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. 

On March 19, 2021, the U.S. Food and Drug Administration (FDA) issued an advisory to healthcare professionals not to use ChloraPrep 3 ml applicators manufactured by BD (Becton, Dickinson and Company) because of the risk of microbial contamination. The product was distributed globally and is labeled with “CareFusion, El Paso, TX.”

On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda^®), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. FDA approved the application three weeks ahead of its goal date.

On March 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta^®) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

On March 3, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena®) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic for lorlatinib.

On February 26, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto^®) in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38–directed monoclonal antibody.

On February 12, 2021, the U.S. Food and Drug Administration (FDA) approved trilaciclib (Cosela™) as the first therapy in its class to reduce the frequency of chemotherapy-induced myelosuppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Trilaciclib inhibits cyclin-dependent kinase 4/6 (CDK 4/6) enzymes to prevent bone marrow damage.   

On February 9, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo^®) for use in patients with locally advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. FDA also granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC previously treated with an HHI or for whom an HHI is not appropriate. 

On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi^®) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified—including DLBCL arising from indolent lymphoma—high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib (Ukoniq™), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.

On February 3, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko^®) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition exon 14 skipping alterations.

On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) in combination with cabozantinib (Cabometyx^®) as first-line treatment for patients with advanced renal cell carcinoma.

On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu^®) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori^®) for pediatric patients aged one year or older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK) positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. 

On December 28, 2020, the U.S. Food and Drug Administration announced that Sunstar Americas, Inc., expanded its October 27, 2020, voluntary recall of Paroex^® chlorhexidine gluconate oral Rinse USP, 0.12%, because of possible contaminated with the bacteria Burkholderia lata.

On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor (Xpovio^®) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refectory multiple myeloma who have received at least one prior therapy. 

On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso^®) as adjuvant therapy after tumor resection for patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. 

On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved the first oral gonadotropin-releasing hormone receptor antagonist, relugolix, (Orgovyx™) for adult patients with advanced prostate cancer. 

On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza™) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who previously received two or more anti-HER2 regimens, at least one of which was for metastatic disease.

To control the COVID-19 coronavirus pandemic, we need public health measures (e.g., masks, physical distancing, hand washing), treatments for infection, and vaccines to prevent infection or serious disease. In 2020, several manufacturers developed COVID-19 vaccines in less than a year. Before that, the fastest a vaccine had been developed was in four years.  

On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for a vaccine to prevent the COVID-19 coronavirus caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States. 

The U.S. Food and Drug Administration (FDA) issued an alert on December 7, 2020, informing patients and healthcare providers that patients may be injured if they wear face masks with metal parts and coatings during magnetic resonance imaging (MRI) exams. Metal parts (e.g., nose pieces, nanoparticles, or antimicrobial coatings that may contain metal such as silver or copper) may become hot and burn patients during MRIs. 

On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved pralsetinib for patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive therapy and who are refractory to radioactive iodine (if radioactive iodine is appropriate).

The COVID-19 coronavirus continues to smother the United States, and nationwide efforts to flatten the curve aren’t lowering cases or preventing deaths. U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, MD, an oncologist by training and profession, addressed the actions needed to combat COVID-19. One in particular is ensuring that clinical trials accurately reflect diverse populations.

On November 25, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to naxitamab (Danyelza^®) in combination with granulocyte-macrophage colony-stimulating factor for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who demonstrate a partial response, minor response, or stable disease to prior therapy.

On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for bamlanivimab, an unapproved agent, to treat mild to moderate cases of the COVID-19 coronavirus. EUAs are not FDA approvals; rather, they authorize use of an unapproved medication in an emergency setting. Bamlanivimab’s initial supply is limited, but the manufacturer announced increased production and distribution in early 2021.

On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score [CPS] ≥ 10) as determined by an FDA-approved test. FDA also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic for selecting patients with TNBC for pembrolizumab.

Lohxa, LLC, issued a voluntary recall of five lots of its alcohol-free chlorhexidine gluconate oral rinse USP 0.12% because of a risk that the product may be contaminated with the bacteria Burkholderia lata. The U.S Food and Drug Administration announced the recall on November 9, 2020. 

In June 2020, the U.S. Food and Drug Administration granted accelerated approval to lurbinectedin (Zepzelca^TM) for adults with metastatic small cell lung cancer (SCLC) whose disease has progressed on or after platinum-based chemotherapy. The approval adds a second choice for patients who experience treatment-resistant SCLC progression, who previously had only topotecan as an option.

On October 2, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma. 

Zanubrutinib (Brukinsa^TM) received U.S. Food and Drug Administration accelerated approval on November 14, 2019, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

On September 4, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pralsetinib (Gavreto™) for adult patients with metastatic, RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq^®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.   

On September 1, 2020, the U.S. Food and Drug Administration (FDA) designated three of the situations involved in BD’s June 30, 2020, previously announced voluntary recall of several models of its Alaris™ system as class I recalls. Class I recall designation indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death.

On September 1, 2020, the U.S. Food and Drug Administration (FDA) approved azacitidine tablets for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are unable to complete intensive curative therapy.

The U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence confirmed that those with immunocompromised systems, including cancer, are at greater risk for serious outcomes or death after contracting the COVID-19 coronavirus.

On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360 CDx assay as the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in patients with metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies in one diagnostic test to guide treatment decisions. 

Cancer clinical trials often collect patient-reported outcome (PRO) data, but the information is generally used just for that trial. Recognizing the value of making it available to healthcare providers everywhere, in July 2020, the U.S. Food and Drug Administration (FDA) launched Project Patient Voice, a pilot program designed to share clinical trial PROs on an easy-to-access website.

On August 5, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep) for adult patients with relapsed or refractory multiple myeloma who received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

On July 31, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tafasitamab-cxix (Monjuvi^®), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant.

On July 30, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq^®) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.

On July 24, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (Tecartus™), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

On July 7, 2020, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi^®) for adult patients with myelodysplastic syndromes, including the following: