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. 

On July 19, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of two lots of varenicline 0.5 mg tablets, two lots of varenicline 1 mg tablets, and eight lots of a varenicline kit of 9.5 mg/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. Varenicline is a treatment to help patients quit smoking and is intended for short-term use. To date, Pfizer has not received any reports of adverse events that have been related to the recall.

On July 1, 2021, the U.S. Food and Drug Administration (FDA) reported Teva Pharmaceuticals’ June 30, 2021, voluntary recall of lot 31328962B of topotecan injection 4 mg/4 ml. The recall was based on a report that a single vial contained a glass particle, a grey silicone particle, and a translucent, colorless cotton fiber.

On July 16, 2021, the U.S. Food and Drug Administration (FDA) approved belumosudil (Rezurock^TM), a kinase inhibitor, for the treatment of chronic graft-versus-host disease (chronic GVHD) in adult and pediatric patients 12 years and older after failure of at least two prior lines of systemic therapy. 

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro^®) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv ([EV], Padcev®), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

Companies marketing the tobacco brands Aspire, Joyetech, Vaporesso, and Voopoo, which were selected through a systematic process, must share information about social media marketing campaigns that target youth, the U.S. Food and Drug Administration (FDA) announced. The requirements include social media advertising documents and marketing plans, such as planned content to target specific audiences, cost of plans, use of partners and influences, and the number of followers and views broken down by age group.

African Americans have a higher cancer burden and face greater obstacles to cancer prevention, detection, treatment, and survival, according to the American Cancer Society. Health organizations such as ONS and the U.S. Food and Drug Administration (FDA) are dedicated to breaking down barriers and improve access to quality care and resources for those patients. To increase cancer awareness in one of the most vulnerable segments of the U.S. population, the FDA’s Oncology Center of Excellence (OCE) dedicated June 17–23, 2021, as National Black Family Cancer Awareness Week.

On June 30, 2021, the U.S. Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn (RylazeTM) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. 

On June 16, 2021, the U.S. Food and Drug Administration (FDA) approved avapritinib (Ayvakit™) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast cell leukemia.

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to infigratinib (Truseltiq™), a kinase inhibitor for patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test. FDA also approved the FoundationOne^® CDx as a companion diagnostic for infigratinib. 

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™), a RAS GTPase family inhibitor, for adult patients with KRAS G12Cmutated 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 May 27, 2021, the U.S. Food and Drug Administration (FDA) approved piflufolastat F 18 (Pylarify^®), a drug for positron-emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in patients with prostate cancer.

On May 21, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to amivantamab-vmjw (Rybrevant™), a bispecific antibody directed against epidermal growth factor receptor (EGFR) and MET receptor, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. FDA also approved the Guardant360^® CDx as a companion diagnostic.

On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

The authority to adopt product standards is one of the most powerful tobacco regulatory tools that the U.S. Congress gives the U.S. Food and Drug Administration (FDA). In April 2021, FDA took full advantage of that authority, announcing two new standards to add menthol to the banned flavor list and ban all flavored cigars. 

On May 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda^®) in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta™), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy.

On April 22, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli), an anti-PD-1 antibody, for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following treatment with a prior platinum-containing regimen.

On April 16, 2021, the U.S. Food and Drug Administration (FDA) reported Care Fusion 303, Inc.’s, recall of the BD Alaris Pump Module 8100 because the device may experience stuck or unresponsive keys during operation. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

The U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products has aggressively fought to obtain tighter tobacco product regulations to protect adolescent lungs. One of those ways is through premarket review, where e-cigarettes and other new tobacco products that were available as of August 8, 2016, were required to submitted applications to FDA for approval by Sept. 9, 2020.

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

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.